remimazolam and Pain

Remimazolam is a novel sedative drug that has been successively approved for procedural sedation and general anesthesia, however, which has not been fully explored due to limited clinical studies and a small sample size. Current clinical studies have focused on the use of remimazolam and propofol for general anesthesia (GA) as indicators of safety outcomes in surgical patients, but different studies have reached different conclusions. The aim of this study was to investigate whether the safety-related outcome indicators in GA were superior to propofol in surgical patients.. We systematically searched PubMed, Cochrane Library, Embase, and Web of Science databases for all published randomized controlled trials comparing remimazolam with propofol for general anesthesia. Data from eligible studies were pooled with relative risk or mean differences to analyze the differences in hemodynamic stability and adverse effects of the two medications.. Eight randomized controlled trials involving 998 participants were included. Compared with propofol, remimazolam had better hemodynamic stability with a lower incidence of hypotension (RR=0.43, 95% CI: [0.34, 0.55], I. In this Meta-analysis, compared with propofol, remimazolam for GA reduced the incidence of hypotension, hypoxemia, nausea and vomiting, dizziness and injection site pain, and had a more stable MAP before and after intubation, which supported that remimazolam is a safer sedative. However, a large sample is needed to validate this finding.

Topics: Anesthesia, General; Benzodiazepines; Dizziness; Humans; Hypnotics and Sedatives; Hypotension; Hypoxia; Nausea; Pain; Propofol; Randomized Controlled Trials as Topic; Vomiting

To improve patient tolerability and satisfaction as well as minimize complications, procedural sedation has been widely used. Propofol is the most widely used agent for induction of anesthesia and sedation by anesthesiologists. With a different mechanism compared to propofol, remimazolam is a new short-acting GABA-A receptor agonist. It is an ester-based benzodiazepine. This meta-analysis aims to clarify the efficacy and safety of remimazolam versus propofol for procedure sedation.. Electronic databases were searched for randomized controlled trials (RCTs) comparing efficacy or safety of remimazolam versus propofol. Meta-analysis were conducted using RStudio with "metafor" package with random-effects model.. A total of twelve RCTs were included in the meta-analysis. The pooled results demonstrated that patients with remimazolam for procedural sedation had lower risk of bradycardia (OR 0.28, 95% CI [0.14-0.57]), hypotension (OR 0.26, 95% CI [0.22-0.32]), and respiratory depression (OR 0.22, 95% CI [0.14-0.36]). There was no difference in the risk of developing postoperative nausea and vomiting (PONV) (OR 0.65, 95% CI [0.15-2.79]) and dizziness (OR 0.93, 95% CI [0.53-1.61]) between the remimazolam and propofol groups. Using remimazolam for procedural sedation is significantly associated with less injection pain compared to propofol (OR 0.06, 95% CI [0.03-0.13]). Regarding the sedation efficacy, there was no difference in sedation success rate or time to loss of consciousness, recover and discharge between the remimazolam and the propofol groups.. Based on our meta-analysis, patients receiving procedural sedation with remimazolam had lower risk of bradycardia, hypotension, respiratory depression and injection pain compared with propofol. On the other hand, there was no difference in sedation success rate, risk of PONV, dizziness, time to LOC, recovery and discharge between these two sedatives.. CRD42022362950.

Topics: Anesthesia; Benzodiazepines; Bradycardia; Conscious Sedation; Dizziness; Humans; Hypotension; Pain; Postoperative Nausea and Vomiting; Propofol; Randomized Controlled Trials as Topic; Respiratory Insufficiency

Remimazolam is a recently approved benzodiazepine for procedural sedation in Taiwan. It is a new type of short-acting γ-aminobutyric acid receptor agonist with the characteristics of non-organ-dependent metabolism, no injection pain, and inactive metabolites. Remimazolam has a mild cardiopulmonary suppressive effect, showing good effectiveness and safety in clinical applications, especially in the elderly, critically ill patients, or patients with hepatic and renal insufficiency. This review aims to provide an overview of the specific basic and clinical pharmacology of remimazolam and provide scientific support for the clinical application of this novel sedative drug in procedural sedation.

Topics: Aged; Anesthesia; Benzodiazepines; Humans; Hypnotics and Sedatives; Pain

Anxiety and pain commonly occur during nerve block, we aimed to investigate the sedation efficacy of different doses of remimazolam with sufentanil in young and elderly patients.. In this randomized trial, patients aged 18-85 years who underwent nerve block was enrolled. All patients received sufentanil 0.08 μg/kg for analgesia. Young patients (age < 65 years) were randomized into the control group (Group C, 0.9% saline), medium-dose remimazolam (Group M, 0.06 mg/kg) and high-dose remimazolam group (Group H, 0.08 mg/kg). Elderly patients (age ≥ 65 years) were randomized into the Group C, low-dose remimazolam group (Group L, 0.04 mg/kg) and Group M. Primary outcome was the success rate of procedure sedation. Respiratory depression and hypoxia were the interested safety outcomes.. Ninety young and 114 elderly patients were enrolled, respectively. In comparison with Groups C and M, young patients in Group H had the highest success rate of procedure sedation (80.0 vs. 73.3 vs. 43.3%, P = 0.006). Elderly patients in Groups M and L had similar success rates of procedure sedation, which were significantly higher than that in Group C (78.9 vs. 78.9 vs. 50.0%, P = 0.007). In elderly patients, the incidence of respiratory depression and hypoxia tended to be higher in Group M than those in Groups L and C (both P < 0.001).. Remimazolam 0.08 mg/kg provided the best sedation efficacy in young patients while remimazolam 0.04 mg/kg with the trend of less respiratory adverse events was more optimal for elderly patients.. http://www.chictr.org.cn/showproj.aspx?proj=122016 .

Topics: Aged; Benzodiazepines; Double-Blind Method; Humans; Hypnotics and Sedatives; Nerve Block; Pain; Respiratory Insufficiency; Sufentanil

Remimazolam tosilate (RT) is a new ultrashort-acting γ-aminobutyric acid subtype A (GABA. Patients were recruited from January to September 2022 in this single-center, prospective, randomized, double-blind trial. A total of 117 patients undergoing selective valve replacement surgery were randomly divided into low-dose RT (0.2 mg/kg) group (group LR), high-dose RT (0.3 mg/kg) group (group HR), or etomidate (1.5 mg/kg) group (group E), respectively. The primary outcome was hemodynamic fluctuations (mean arterial pressure fluctuation value [∆MAP]; heart rate fluctuation value [∆HR]) during anesthesia induction. Secondary outcomes included the incidence of adverse drug reactions (injection pain and myoclonus) and adverse cardiovascular events, vital signs at different time points and the cumulative doses of vasoactive drugs.. The hemodynamic fluctuations (∆MAP) in group LR and group E were significantly lower than that in group HR. In addition, the incidence of hypotension and the cumulative norepinephrine doses in group E and group LR were also significantly lower than that in group HR. Furthermore, the incidence of injection pain and myoclonus in group LR and group HR were less frequently recorded compared with group E. There were no significant differences in terms of ∆HR, tachycardia, hypertension, severe bradycardia, vital signs at different time points, lactic acid and blood glucose between both groups.. Compared with etomidate, low-dose RT (0.2mg/kg) can not only provide stable hemodynamic parameters but also cause fewer adverse reactions when used for anesthesia induction in patients with cardiac disease.

Topics: Anesthetics, Intravenous; Cardiac Surgical Procedures; Etomidate; Hemodynamics; Humans; Myoclonus; Pain; Propofol; Prospective Studies

Remimazolam tosilate (RT) is a novel short-acting GABA (A) receptor agonist that has a rapid recovery from procedural sedation and can be fully reversed by flumazenil. To date, there have been relatively few articles comparing RT and propofol for general anesthesia. This study aimed to assess the efficacy and safety of RT with or without flumazenil compared with propofol in general anesthesia for day surgery.. 115 patients scheduled for day surgery were randomized into three groups: RT (n = 39), RT + flumazenil (n = 38) and propofol (n = 38). The primary endpoints were anesthesia induction time and time until fully alert. Anesthesia success rate, bispectral index (BIS) values, injection pain, opioid and vasopressor dosages, postoperative recovery profiles and perioperative inflammatory and cognitive changes were assessed. Any adverse events were recorded.. Induction times were similar among the three groups (P = 0.437), but the median time until fully alert in patients treated with RT was longer than that of the propofol or RT + flumazenil groups (17.6 min vs. 12.3 min vs. 12.3 min, P < 0.001). The three groups had comparable postoperative recovery quality and inflammatory and cognitive state changes (P > 0.05). Smaller percentages of patients who received RT (26.3%) and RT + flumazenil (31.6%) developed hypotension during anesthesia maintenance compared with propofol (68.4%), and consequently less ephedrine (P < 0.001) and phenylephrine (P = 0.015) were needed in the RT group. Furthermore, serum triglyceride levels were lower (P < 0.001) and injection pain was much less frequent in the RT with or without flumazenil groups compared with the propofol group (5.3% vs. 0% vs. 18.4%).. RT permits rapid induction and comparable recovery profile compared with propofol in general anesthesia for day surgery, but has a prolonged recovery time without flumazenil. The safety profile of RT was superior to propofol in terms of hypotension and injection pain.. The study was registered at Chinese Clinical Trial Registry http://www.chictr.org.cn/ (Registration date: 19/7/2021; Trial ID: ChiCTR2100048904).

Topics: Ambulatory Surgical Procedures; Flumazenil; Humans; Hypotension; Pain; Propofol; Prospective Studies

Remimazolam is a new benzodiazepine with a short half-life, good efficacy, and safety profiles in general anesthesia. Combining esketamine with propofol (P + E) could reduce propofol consumption and injection pain. It is, however, unclear if a low dose of remimazolam co-administrated with esketamine (R + E) is comparable to the increasingly used P + E for surgical abortion with general anesthetic. We conducted a double-blind randomized controlled trial to compare the efficacy and safety of R + E and P + E. Two hundred patients scheduled for a surgical abortion were randomized to receive remimazolam 0.3 mg/kg plus esketamine 0.3 mg/kg (R + E), and propofol 2 mg/kg plus esketamine 0.3 mg/kg (P + E). Sedative effectiveness was evaluated by measuring the time to lose consciousness (LOC), recovery time, and successful sedation rate. Safety was assessed by hemodynamics and adverse events during and postoperation. The time to LOC and recovery time in R + E was 5 s shorter and 1 min longer than that in P + E, respectively (both p < 0.001). Success sedation rate did not differ between groups (p = 0.73). Bradycardia incidence and injection site pain were less frequent in the R + E group than that in the P + E group. More rash was observed in the R + E group compared with the P + E group (32% vs. 5%, p < 0.001), but all were mild (only chest rash) and resolved subsequently. Low dose of remimazolam when combined with esketamine has favorable profiles with rapid onset and recovery, but mild hemodynamic side effects and adverse events. It can be used as an alternative for surgical abortion with general anesthetic.

Topics: Anesthetics, General; Benzodiazepines; Exanthema; Female; Humans; Pain; Pregnancy; Propofol

Remimazolam tosilate (RT) is a novel ultrashort-acting γ-aminobutyric acid subtype A (GABA. Patients were recruited into this single-center, prospective, randomized, double-blind trial from October 2022 to June 2023. A total of 150 hypertensive elderly undergoing non-cardiac surgery were randomly assigned into 0.2 mg/kg RT group (Group RL), 0.3 mg/kg RT group (Group RH) and 0.3 mg/kg etomidate group (Group E). The primary outcome of the study was haemodynamic changes (mean arterial pressure fluctuation value -∆MAP and heart rate fluctuation value -∆HR) observed during anaesthesia induction. Secondary outcomes included incidence of adverse cardiovascular events and adverse drug reactions (injection pain and myoclonus), cumulative doses of vasoactive drugs and vital signs at different time points.. Patients in Group E and Group RL had significantly lower haemodynamic fluctuations (∆MAP), lower incidence of hypotension and cumulative dose of ephedrine than subjects in Group RH. Patients in groups RL and RH had significantly lower incidence of injection pain and myoclonus compared with patients in group E. The results showed no statistically significant differences in ∆HR, hypertension, bradycardia, tachycardia, and time to loss of eye-opening reflex and start of intubation, and vital signs at different time points among the three groups.. Use of low-dose RT (0.2 mg/kg) for induction of non-cardiac surgical anaesthesia in elderly hypertensive patients is more effective in maintaining haemodynamic stability and has fewer adverse effects compared with etomidate.

Topics: Aged; Anesthesia, General; Etomidate; Hemodynamics; Humans; Hypertension; Myoclonus; Pain; Propofol; Prospective Studies

Topics: Adolescent; Adult; Aged; Benzodiazepines; Gastroscopy; Humans; Middle Aged; Pain; Propofol; Saline Solution; Young Adult

Remimazolam tosilate (HR7056, RT), a novel ultrashort-acting benzodiazepine, can be used for procedural sedation and general anaesthesia. However, few studies have focused on the sedative effect of RT during gastrointestinal endoscopy in elderly patients. The purpose of this study is to compare the sedative effect of RT and propofol for gastrointestinal endoscopy in elderly patients.. Data from 77 patients were analysed. The success rate of sedation in both groups was 100%. The time to LOC (MOAA/S score ≤ 1) in the RT group was longer than that in the propofol group (20.7 ± 6.1s vs. 13.2 ± 5.2s, P < 0.001). There were fewer patients in the RT group reporting injection pain than that in the propofol group (0/39 vs. 5/38, P = 0.025). Haemodynamic events and respiratory depression in the RT group were less frequent than those in the propofol group ((6/39 vs. 17/38, P = 0.005), (2/39 vs. 9/38, P = 0.026), respectively). The number of supplemental doses after successful induction in the RT group was greater than that in the propofol group (4/9/11/13/1/1 vs. 8/4/18/6/2/0 requiring 0, 1, 2, 3, 4 or 5 supplemental doses, P = 0.014). The characteristics of the patients enrolled, postoperative parameters of the patients, and patients' and physician's satisfaction of the procedure were comparable in the two groups.. Compared with propofol, RT can be safely and effectively used for gastrointestinal endoscopy sedation in elderly patients, and the incidence of sedation-related adverse reactions, especially haemodynamic events and respiratory depression, is lower. When RT is used, the number of supplemental doses after successful induction may increase slightly.. Chictr.org.cn ChiCTR2000040498. Retrospectively registered (date of registration: December 1, 2020).

Topics: Aged; Benzodiazepines; Endoscopy, Gastrointestinal; Humans; Hypnotics and Sedatives; Pain; Propofol; Prospective Studies; Respiratory Insufficiency

Remimazolam is an ultrashort-acting benzodiazepine that is potentially a practical option for procedural sedation in colonoscopy.. To test the hypothesis that remimazolam could provide a noninferior discharge time to propofol for ambulatory colonoscopy.. A prospective, randomised, double-blind, noninferiority clinical trial.. Ambulatory endoscopy centre.. A total of 132 adult participants undergoing ambulatory colonoscopy were enrolled.. Participants were randomly assigned in a 1 : 1 ratio to receive propofol or remimazolam for sedation.. The primary outcome was discharge time after a colonoscopy, assessed using the Modified Postanaesthetic Discharge Scoring System scale. Secondary outcomes included induction time, emergence time, the extent of recovery upon arrival in the postanaethesia care unit, fatigue, endoscopist and patient satisfaction and adverse events.. The median discharge time was 24 min in the remimazolam group versus 21 min in the propofol group, with a difference of 2 min [95% confidence interval (CI), 0 to 4 min], meeting the criteria for noninferiority. Injection pain occurred in 11 of 66 (17%) participants receiving remimazolam versus 32 of 66 (49%) participants receiving propofol ( P  < 0.001); hypotension occurrence was 20% versus 47%, ( P  < 0.001), respectively, and bradycardia 6% versus 20%, ( P  = 0.019), respectively. Compared with propofol, the patient satisfaction score was higher in the remimazolam group ( P  < 0.001).. For sedation in ambulatory colonoscopy, compared with propofol, remimazolam provides a noninferior discharge time. Furthermore, remimazolam is associated with less injection pain, lower risks of hypotension and bradycardia, and improved patient satisfaction.. Chinese Clinical Trial Registry, identifier: ChiCTR2100048678.

Topics: Adult; Benzodiazepines; Bradycardia; Colonoscopy; Humans; Hypnotics and Sedatives; Hypotension; Midazolam; Pain; Patient Discharge; Propofol; Prospective Studies

Propofol is widely used for sedation of hysteroscopy. It can cause injection pain, respiratory depression, and hypotension. Remimazolam is a novel ultra-short-acting benzodiazepine. Clinical practice has found that the use of remimazolam alone often leads to body movement during hysteroscopy, which decreases the safety and comfort. Here this study is to investigate whether remimazolam combined with low-dose propofol can improve the sedation effect and safety of hysteroscopy.. In this prospective, randomized, parallel-controlled trial, women (18 to 60 years) undergoing hysteroscopy were randomly assigned to receive propofol (Group P), remimazolam tosylate (Group R), or remimazolam tosylate plus propofol (Group RP). Intraoperative sedation depth was kept at the bispectral index (BIS) value of 40-60. 6 μg/kg alfentanil was used for analgesic before sedation. Intraoperative low pulse oxygen saturation (SpO. From February to July 2022, 193 patients were recruited and randomly assigned to group P (n=64), group R (n=64), or group RP (n=65). There was no significant inter-group difference of the intraoperative BIS values. The incidence of low SpO. Remimazolam tosylate combined with low dose of propofol improved sedation and safety in hysteroscopy, and may be a more ideal sedative method for hysteroscopy.

Topics: Benzodiazepines; Dizziness; Female; Humans; Hypnotics and Sedatives; Hypotension; Hysteroscopy; Nausea; Pain; Pregnancy; Propofol; Prospective Studies; Vomiting

Propofol-induced injection pain (PIP) is a well-known problem in general anesthesia. We hypothesized that pre-treatment with remimazolam prevents PIP in patients undergoing abortion or curettage.. The incidence of patients with PIP was higher in group NS than that in group Lido and group Remi (75.7, 44.3, and 42.9%, respectively,. Our findings indicate that pre-treatment with remimazolam reduced the incidence and intensity of PIP in abortion or curettage patients, equivalent to that of lidocaine without severe adverse effects.. Chinese Clinical Trial Registry (identifier: ChiCTR2100041805).

Topics: Abortion, Induced; Adult; Anesthetics, Intravenous; Benzodiazepines; Dilatation and Curettage; Double-Blind Method; Female; Humans; Lidocaine; Pain; Pregnancy; Propofol; Prospective Studies; Young Adult

The optimal sedation regime during endoscopy remains controversial, especially for elderly outpatients. In this study, we compared the efficacy and safety between remimazolam tosilate (RT) and etomidate-propofol (EP) in elderly outpatients undergoing colonoscopy.. A total of 260 elderly outpatients undergoing sedative colonoscopy were randomized into two groups. Patients in the RT group received a 0.075-mg/kg maintenance dose of remimazolam following an initial dose of 0.15 mg/kg, whereas patients in the EP group (10 mL:20 mg etomidate plus 10 mL:100 mg propofol) received a 0.05-mL/kg maintenance dose following an initial dose of 0.1 mL/kg to maintain a Modified Observer's Assessment of Alertness/Sedation score of ≤3 during the procedure. The primary endpoint was the success of the procedure. Secondary endpoints included time metrics, hemodynamics, consumption of fentanyl, etomidate, propofol, and remimazolam, intraoperative body movement, patient and endoscopist satisfaction scores, supplemental dose of sedative and fentanyl, and incidence and severity of adverse events.. The procedure success rate was 96.52% in the RT group and 100% in the EP group. The difference in procedure success rate between the RT and EP groups was -3.48% (95% confidence interval: -6.81%, -0.15%). Four patients in the RT group required rescue midazolam. Compared with patients in the RT group, the onset time of the EP group was significantly lower (. RT may have non-inferior efficacy and a higher safety profile than EP in elderly outpatients undergoing colonoscopy, which suggests that RT may be more suitable for elderly outpatients undergoing colonoscopy.

Topics: Aged; Benzodiazepines; Colonoscopy; Dose-Response Relationship, Drug; Etomidate; Female; Humans; Male; Muscle, Skeletal; Outpatients; Pain; Propofol; Prospective Studies; Single-Blind Method; Tremor

Patients with myotonic dystrophy (DM) are highly sensitive to anesthetics, muscle relaxants, and opioids, necessitating appropriate anesthetic management. Recently, remimazolam, an ultra-short-acting benzodiazepine, has been approved for use as a general anesthetic in Japan, and patients with DM have reportedly been treated with remimazolam. However, to the best of our knowledge, no study has reported on endotracheal intubation without the use of muscle relaxants under anesthetic management with remimazolam, nor on the combination of remimazolam and ketamine.. A 23-year-old man was referred to our hospital for right parotidectomy and diagnosed with DM just before surgery. At the surgeon's discretion, he was scheduled to undergo nerve monitoring to preserve the facial nerve.. Myotonic dystrophy.. We planned total intravenous anesthesia without muscle relaxants and selected remimazolam for anesthesia. Our aim was to prevent the intraoperative or postoperative complications associated with propofol and inhalational anesthetics. Additionally, we selected multimodal analgesia, including ketamine, to avoid opioid use. General anesthesia was induced with ketamine 30 mg, remifentanil 0.72 μg/kg/min, and remimazolam 12 + 6 mg. Endotracheal intubation was performed under videolaryngoscopy without the use of muscle relaxants. For postoperative analgesia, we administered additional doses of ketamine 20 mg and acetaminophen 1000 mg, and the surgeons infiltrated 8 mL of xylocaine 0.5% with epinephrine into the skin incision before starting the surgery. Intraoperative anesthesia was maintained with remimazolam 0.9 to 1.0 mg/kg/h and remifentanil 0.26 to 0.50 μg/kg/min. Flumazenil was administered for rapid awakening and safe extubation. All vitals, including the bispectral index, were stable during surgery.. The patient did not develop facial nerve paralysis, sore throat, or hoarseness, nor did he have any memory of the surgery. Good postoperative analgesia was achieved.. We achieved effective anesthetic management using remimazolam without muscle relaxants in a patient with DM. Furthermore, the combination of remimazolam and ketamine provided good sedation and postoperative analgesia.

Topics: Adult; Anesthetics, Intravenous; Benzodiazepines; Humans; Ketamine; Male; Muscles; Myotonic Dystrophy; Pain; Remifentanil; Young Adult