piperidines and Genital-Diseases--Female

The aim of this study was to report the gynecologic safety findings from the Generations trial, a phase 3 study of the selective estrogen receptor modulator (SERM), arzoxifene.. A predefined objective of the trial was to evaluate the effects of arzoxifene on the genital tract. Gynecologic examinations were performed yearly, and further gynecologic assessment, including endometrial biopsy, was performed in a predefined subset of women and in those who developed vaginal bleeding.. Overall, 9,354 women were randomized (4,678 to placebo, 4,676 to arzoxifene 20 mg/d). There were 13 adjudicated cases of endometrial cancer (placebo, 4 cases; arzoxifene, 9 cases: P = 0.165) and 6 cases of endometrial hyperplasia (placebo, 2 cases; arzoxifene, 4 cases). Endometrial thickness, assessed at 24- and 36-month transvaginal ultrasounds in a subset of women, increased slightly in women assigned to arzoxifene compared with baseline and women in placebo. At the last measurement, 3 (1.7%) women assigned to placebo and 21 (10.2%) assigned to arzoxifene had an endometrial thickness greater than 5 mm (P < 0.001 for difference between treatment groups). Endometrial polyps were more common in women treated with arzoxifene (n = 37) than in women treated with placebo (n = 18; P < 0.05). Vulvular and vaginal inflammation, including mycotic infections, and vaginal discharge were reported more frequently in women treated with arzoxifene than in women treated with placebo, as were urinary tract infections.. Gynecologic events were generally more common in women treated with arzoxifene than in women treated with placebo. The gynecologic effects of arzoxifene seem to differ from those of raloxifene, although both SERMs have a benzothiophene structure. Although all SERMs influence cells through the estrogen receptor, they need to be evaluated independently in terms of their effects on various tissues, including the genital tract.

Topics: Aged; Aged, 80 and over; Endometrial Neoplasms; Endometrium; Female; Genital Diseases, Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Piperidines; Placebos; Polyps; Postmenopause; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators; Thiophenes; Uterine Hemorrhage; Vaginitis; Vulvitis

Remifentanil is associated with increased incidence of post-anaesthetic shivering (PAS). The aim of this study was to compare the effects of intraoperative high and low doses of remifentanil on PAS.. We investigated 50 consecutive patients, aged <60 yr, who underwent gynaecological laparotomy. Patients who underwent prolonged surgery (>4 h) were excluded from the study. Anaesthesia throughout surgery was maintained with i.v. propofol and remifentanil, and epidural ropivacaine, and no nitrous oxide was used. Fifty patients were randomly assigned to receive intraoperative remifentanil at 0.1 microg kg(-1) min(-1) (low-dose group, n=25) or 0.25 microg kg(-1) min(-1) (high-dose group, n=25) until the end of surgery. Intraoperative analgesia was achieved by a fixed infusion rate of remifentanil and titrated epidural ropivacaine. PAS was evaluated by nursing stuff over the first hour after surgery.. PAS occurred more frequently in the high-dose group than in the low-dose group (60% vs 20%, P=0.009). None of the patients complained of pain during the observation period due to epidural analgesia. There were no significant differences in rectal or palm skin temperature after extubation between the two dose groups.. Remifentanil-induced PAS is not a phenomenon of intraoperative hypothermia. The higher incidence of PAS with higher doses of remifentanil probably reflects acute opioid tolerance and stimulation of N-methyl-d-aspartate receptors, similar to hyperalgesia. We conclude that patients administered high doses of remifentanil are sensitive to shivering after sudden drug withdrawal.

Topics: Adult; Anesthetics, Intravenous; Body Temperature; Dose-Response Relationship, Drug; Female; Genital Diseases, Female; Humans; Intraoperative Period; Middle Aged; Piperidines; Postoperative Complications; Remifentanil; Shivering

We wanted to compare totally intravenous anaesthesia with propofol and remifentanil to mixed anaesthesia with isoflurane and fentanyl in terms of postoperative pain, nausea, length of stay and costs.. We present a prospective, non-randomised, anaesthetist-based double-blind study with a cost-utility analysis on consecutive patients undergoing laparoscopic gynaecologic day-care surgery. Premedication consisted of paracetamol and diclofenac. The mixed anaesthesia group received propofol, isoflurane, fentanyl, vecuronium, N2O and O2,the total intravenous group propofol, remifentanil, vecuronium, N2O and O2. Paracetamol and ketobemidon, metoklopramid and ondansetron were given to relieve pain and nausea, respectively. Patients were asked to report pain and nausea on a visual analogue scale after 4 and 24 hours.. 26 mixed and 27 totally intravenous patients were comparable by age, body mass index and ASA (American Society of Anesthesiologists) scores. There was a protocol violation, as fewer totally intravenous patients received pre-medication (16/26 vs. 8/27 p < 0.001). Totally intravenous patients had significantly higher consumption of ketobemidon (mean 2.35 vs. 5.43 mg/24 h p < 0.004). Within the totally intravenous group, scores for pain at 24 hours were significantly higher as compared with 4-hour scores (p = 0.012). At 24 hours, scores for nausea were significantly higher for the totally intravenous group (1.87 vs. 3.21 p = 0.014). Length of stay did not differ significantly (mean 649 vs. 729 min p > 0.2). Costs of medication were significantly higher for the totally intravenous group (mean 211 vs 285 NOK p <0.001).. The use of totally intravenous anaesthesia led to more nausea and more expenses than mixed anaesthesia in laparoscopic gynaecologic day-care surgery. No recommendations for either method can be made because of the non-randomized design.

Topics: Anesthetics, Intravenous; Cost-Benefit Analysis; Double-Blind Method; Drug Costs; Female; Fentanyl; Genital Diseases, Female; Humans; Isoflurane; Laparoscopy; Length of Stay; Nitrous Oxide; Pain, Postoperative; Piperidines; Postoperative Nausea and Vomiting; Preanesthetic Medication; Propofol; Prospective Studies; Remifentanil; Vecuronium Bromide

Topics: Abortion, Induced; Adolescent; Adult; Aged; Ambulatory Care; Analgesia; Benzophenones; Dipyrone; Drug Combinations; Female; Genital Diseases, Female; Humans; Middle Aged; Piperidines

Topics: Adolescent; Adult; Aged; Animals; Benzilates; Biliary Tract Diseases; Blood Circulation; Cardiovascular System; Cats; Central Nervous System; Child; Child, Preschool; Clinical Trials as Topic; Dogs; Female; Gastrointestinal Diseases; Genital Diseases, Female; Guinea Pigs; Humans; Infant; Infant, Newborn; Male; Mice; Middle Aged; Muscle Contraction; Muscles; Muscular Diseases; Neoplasms; Piperidines; Pupil; Rabbits; Rats; Respiration; Respiratory Tract Diseases; Salivation; Urologic Diseases

To describe a single manual infusion technique for total intravenous anesthesia with remifentanil and propofol.. Descriptive study of a series of 30 women classified as ASA 1 or 2 who received total intravenous anesthesia by means of a single manual infusion of a combination of remifentanil and propofol for laparoscopic gynecology procedures. The patients received 5 microg of remifentanil plus 2 mg of propofol per milliliter of normal saline solution. The rate of infusion was established according to remifentanil requirements and modified in accordance with the bispectral (BIS) index.. Sufficient hemodynamic stability was maintained in all patients, with BIS values between 40 and 60. The average time until awakening was 5.2 minutes after the anesthetic infusion had been halted.. Total intravenous anesthesia by means of a single manual infusion of remifentanil and propofol provided appropriate anesthetic and surgical conditions, with rapid, predictable awakening.

Topics: Adult; Anesthetics, Intravenous; Female; Genital Diseases, Female; Humans; Infusions, Intravenous; Laparoscopy; Middle Aged; Piperidines; Propofol; Remifentanil; Young Adult

Topics: Adult; Aged; Androstanes; Anesthesia; Female; Genital Diseases, Female; Humans; Middle Aged; Neuromuscular Depolarizing Agents; Neuromuscular Nondepolarizing Agents; Piperidines

Topics: Central Nervous System Stimulants; Depression; Depressive Disorder; Female; Genital Diseases, Female; Gynecology; Humans; Obstetrics; Piperidines