Comparison of the effect of intravenous dexmedetomidine versus intravenous fentanyl on quality of recovery in patients undergoing laparoscopic cholecystectomy: A double blind randomized clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the effect of intravenous dexmedetomidine versus intravenous fentanyl on quality of recovery using QoR 15 questionnaire.
研究概览
简要总结
This randomized, double-blind, control study will be conducted on 60 patients after the institutional ethical committee approves.
The study will be carried out at our institute for over 12 months.
Sampling will be done based on computer generated randomization, and allocation concealment will be done using a sealed, opaque envelope. Study medications will be prepared by anesthesiologists who will not be involved in further patient care or data collection. The anesthesiologist and post-anaesthesia care unit (PACU) nurse involved in data collection will not be aware of the groups.All the patients wil be randomly allocated into two groups of 30 each.Patients will be randomized into two groups: intervention drugs will be given to the patient according to group allocation10 minutes before induction then infusion will be continued till the end of surgery.
Group B will receive IV Dexmedetomidine (1µg/kg over 10 min followed by 0.5µg/kg continuous infusion).
Group A will receive IV fentanyl (2µg/ kg over 10 min followed by an infusion of 0.5 µg/kg/h).
Intraoperative hemodynamic parameters like heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), saturation (%) will be continuously monitored throughout the surgery. Intraoperative adverse effects like bradycardia, hypotension, and arrhythmias will be noted and managed accordingly and Adverse drug reactions (ADR) reporting to the committee will be done in all cases. At the end of the surgery, intervention drugs infusion according to group allotment will be stopped.
The patients will be then transferred to the post-anaesthesia care unit (PACU) and monitored for pain at 0, 30 min, 1hour, 2hour, and 6hour using an NRS Score.A pre-tested and pre-validated QoR-15 questionnaire will be used for the postoperative quality of recovery analysis at 12hour ,24hour, 36hour and 48 hours, patients will be asked to complete the QoR15 questionnaire in the post anaesthetic care unit (PACU). The questionnaire consists of 15 items, and the total sum of the scores ranged from 0 to 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with body mass index between 18.5 to 24.9kg/m
- •3.Patients posted for laparoscopic cholecystectomy.
排除标准
- •1.Patient refusal.
- •2.Known allergy to the drugs to be used.
- •3.Patients who are alcoholic or drug abuser.
- •4.Patients with body mass index greater than 30kg/m
- •5.Patients with clinically significant neurologic, psychiatric, cardiovascular, renal and hepatic diseases.
- •6.Patients who received an opioid analgesic medication within a 24 hour period before surgery.
- •7.Patients with upper respiratory tract infection, asthma, COPD.
- •8.Patients with chronic pain.
结局指标
主要结局
To compare the effect of intravenous dexmedetomidine versus intravenous fentanyl on quality of recovery using QoR 15 questionnaire.
时间窗: At 12 hours, 24 hours,36 hours, 48 hours.
次要结局
- To compare the postoperative pain using NRS (numeric pain rating scale).(Just after surgery.)
- To compare the total analgesic consumption in postoperative period.(Just after surgery.)
- To compare change in hemodynamic parameters (blood pressure, mean arterial pressure, heart rate, saturation) in perioperative period.(Baseline before induction.)
- Complications of any used drugs if any.(nil)
研究者
Garvita Singh Parmar
Uttar Pradesh University of Medical Sciences, Saifai ,Etawah.