Comparison between the effects of two different doses of remifentanil infusion during laparoscopy assisted vaginal hysterectomy in terms of heart rate and mean arterial pressure

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Comparison of two doses of remifentanil for LAVH: After obtaining Institutional Ethics Committee clearance and explaining the study in detail, written informed consent will be procured from patients. The patients are randomized into two groups high dose of remifentanil (group H) and low dose of remifentanil (group L) by a computer generated randomization list prepared by an anaesthesiologist not involved in the study. The principal investigator is blinded to the computer generation of random numbers and sealed envelope method will be used during the conduct of study. The allotted patients will be kept nil per oral as per the standard fasting guideline protocol. On the night prior and morning of surgery patient will be premedicated with pantoprazole tablet 40 mg, ondansetron tablet 4 mg and alprazolam tablet 0.25 mcg. Once inside the theatre standard ASA monitors (non invasive BP, pulseoximetry and 3 lead ECG) will be attached. Every patient will be premedicated with 0.2 mg glycopyrrolate. IV induction will be done with Inj Propofol 1.5‐2 mg/kg followed by muscle relaxant will be given which is Inj. Vecuronium 0.1 mg/kg.Then a bolus dose of 1mcg/ kg will be given prior to intubation to all patients. Soon after intubation patients in group L will be started on 0.1 mcg/kg/hr of continuous infusion of remifentanil and group H will be started on 0.2mg/kg/hr of continuous infusion of remifentanil. Continuous monitoring of the patients for MAP and HR changes will be done. One value will be taken at the 0 minute, then at 5 minute intervals for 1st 30 minutes, then at 10 minutes interval from 30‐60 minutes and 15 minutes till the completion of surgery. Every patient will receive Paracetamol injection 1gm and Tramadol 100 mg once the skin closure is started. 10 minutes after completion of the above infusion, remifentanil infusion will be stopped. Once the procedure completed patient will be extubated and shifted to recovery. 20% rise in MAP or HR will be considered as inadequate hemodynamic stability intraoperatively and will be treated with bolus dose of 25 mcg of remifentanil till the pulse rate and BP comes back to normal. Control Intervention1: Not applicable: Not applicable CONDITION: PRIMARY OUTCOME: Mean arterial pressureTimepoint: 0 min, 5 min, 10 min, 15 min, eevery 10 minutes thereafter SECONDARY OUTCOME: Heart rate variationTimepoint: 0 min, 5 min, 10 min, 15 min, eevery 10 minutes thereafter INCLUSION CRITERIA: Age 18 years or more ASA I and II Elective LAVH surgery
Epistemonikos ID: 47125ec60cf1134a20d2d3169d38825d1b8ce6ab
First added on: Oct 08, 2026