Remifentanil Versus Fentanyl During Laparoscopic Hysterectomy

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
Study design‐ Prospective, single‐center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer‐generated list of random numbers. study protocol‐ 1. anesthesia is induced and maintained with propofol 2. Ventilation is performed with volume/pressure control mode with a tidal volume of 6‐8 ml/kg, a frequency of 10‐12/min and a positive end‐expiratory pressure of 5 cm H2O aiming at normocapnia. 3. Tracheal intubation is performed 2 min after administration of the muscle relaxant 0.6‐1.2 mg/kg rocuronium. 4. Patients in the study group will receive 0.2 mcg/kg/min Remifentanil 5. Fentanyl at the dose of 100mcg will be administered to all the patients in the control group 6. The gynecologist, surgical staff and patients will be blinded to group allocation. 7. During surgery additional muscle relaxant will be given only when asked by the gynecologist and will be mentioned in the anesthesiologic chart 8. The investigator managed the insufflation of the abdomen to 12 mmHg pneumoperitoneum. 9. Patients will be placed in the lithotomy position in a 30‐degree head‐down body position. 10. Antibiotic prophylaxis is given for all patients 11. The gynecologists will evaluate the surgical conditions before a colpotomy is made in a circumferential fashion around the cervix and toward the end of the surgery on four‐point rating scale (1: excellent, 2: good, 3: acceptable 4: poor) 12. The gynecologists will also rate surgical space conditions on a numeric rating scale (NRS), where NRS 0 indicated optimal surgical space conditions and NRS 100 indicated unacceptable surgical space conditions and an intervention is needed to secure acceptable surgical space6
Epistemonikos ID: ac33c350681419d2b20b45494ff3640f37bc9838
First added on: May 06, 2024