Comparison of Quality of Recovery with Intraoperative Esmolol versus Placebo in Adults Undergoing Lumbar Spine Fixation Surgery in Prone Position under general anaesthesia (QuaRELS Study): a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To compare quality of recovery (QoR-15) with intraoperative esmolol versus placebo in adults undergoing lumbar spine fixation surgery by QoR-15 score at 24h.
研究概览
简要总结
Lumbar spine fixation surgery is frequently associated with poor postoperative recovery due to advanced age, baseline pain, limited mobility, acute postoperative pain and high perioperative opioid requirements. Early postoperative recovery is a key determinant of long-term functional outcomes following spine surgery. Esmolol is an ultra-short-acting beta-one selective adrenergic blocker commonly used intraoperatively for heart rate and blood pressure control and has demonstrated analgesic and opioid sparing effects in various surgical procedures. However, its impact on the overall quality of recovery after spine surgery has not been adequately studied.
The study hypothesizes that intraoperative esmolol infusion improves postoperative quality of recovery compared to placebo, as assessed by the Quality of Recovery 15 score. This study is a prospective randomized double blind placebo controlled trial designed to evaluate the effect of intraoperative esmolol on postoperative recovery in adults undergoing lumbar spine fixation surgery in the prone position under general anesthesia
A total of 96 adult patients ASA physical status I to III scheduled for multi-level lumbar spine fixation surgery will be randomized into two groups The esmolol group will receive an intravenous loading dose of esmolol 0.5 mg per kg at induction followed by a continuous infusion 50 to 150 microgram per kg per minute titrated to maintain heart rate and mean arterial pressure within 20 percent of baseline until extubation The placebo group will receive an equivalent volume of normal saline following an identical protocol perioperative anesthesia management will be standardized in both groups
This study aims to determine whether intraoperative esmolol can enhance postoperative recovery while reducing opioid consumption and maintaining perioperative hemodynamic stability in patients undergoing lumbar spine fixation surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I-III patients.
- •Age greater than 18 years.
- •Undergoing lumbar spine fixation surgery on more than 1 level under general anesthesia.
排除标准
- •Patient’s refusal.
- •Patients already on beta blockers.
- •Cardiac arrhythmias associated with hemodynamic instability.
- •Preoperative bradycardia (Heart rate less than 60 per min).
- •Pre-existing hypotension (Systolic BP less than 90 mmHg or Mean arterial BP less than 65 mmHg).
- •Lung diseases (asthma or chronic obstructive pulmonary disease).
- •Medical history of hypersensitivity to esmolol.
- •Emergency spine surgery.
结局指标
主要结局
To compare quality of recovery (QoR-15) with intraoperative esmolol versus placebo in adults undergoing lumbar spine fixation surgery by QoR-15 score at 24h.
时间窗: 24 hours after surgery.
次要结局
- QoR-15 score(at 48 h post operatively)
- Difference in individual domains of QoR-15 score(at 24 and 48 hours)
- Cumulative post operative opioid consumption in iv(morphine equivalents)
- Difference in intraoperative fentanyl requirements(Intraoperative period)
- Difference in hemodynamic response(At 3 min after intubation and 3 min after extubation)
- Difference in frequency of hypotensive episode(Intraoperative period)
研究者
Dr Sushruta Chakraborty
AIIMS Bhubaneswar