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CTRI Number  CTRI/2026/02/103668 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Esmolol on Recovery after Spine Surgery under General Anaesthesia 
Scientific Title of Study   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 
Trial Acronym  QuaRELS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushruta Chakraborty 
Designation  Senior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anaesthesiology and critical care, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha

Khordha
ORISSA
751019
India 
Phone  9330520543  
Fax    
Email  sushrutachakraborty1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Satyajeet Misra 
Designation  Professor & HOD 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology and critical care, Room No 409, Academic Block, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha

Khordha
ORISSA
751019
India 
Phone  9438884048  
Fax    
Email  misrasatyajeet@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Satyajeet Misra 
Designation  Professor & HOD 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology and critical care, Room No 409, Academic Block, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha

Khordha
ORISSA
751019
India 
Phone  9438884048  
Fax    
Email  misrasatyajeet@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar, Bhubaneswar 751019, Odisha, India 
 
Primary Sponsor  
Name  Satyajeet Misra 
Address  Room no 409, Academic Block AIIMS Bhubaneswar, Bhubaneswar 751019, Odisha, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushruta Chakraborty  AIIMS Bhubaneswar  Department of Anesthesiology and Critical Care, 4th floor, Room No 409, Academic Block
Khordha
ORISSA 
9330520543

sushrutachakraborty1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Student Research, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Esmolol infusion  Intraoperative esmolol bolus of 0.5 mg/kg over 1 minute followed by infusion at rate 50-150 mcg/kg/hr according to heart rate and blood pressure in lumbar spine fixation surgery. 
Comparator Agent  Placebo infusion ( normal saline )  Intraoperative normal saline bolus and infusion at similar rate to intervention group during lumbar spine fixation surgeries. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)ASA grade I-III patients.
2)Age greater than 18 years.
3)Undergoing lumbar spine fixation surgery on more than 1 level under general anesthesia
 
 
ExclusionCriteria 
Details  1)Patient’s refusal.
2)Patients already on beta blockers.
3)Cardiac arrhythmias associated with hemodynamic instability.
4)Preoperative bradycardia (Heart rate less than 60 per min).
5)Pre-existing hypotension (Systolic BP less than 90 mmHg or Mean arterial BP less than 65 mmHg).
6)Lung diseases (asthma or chronic obstructive pulmonary disease).
7)Medical history of hypersensitivity to esmolol.
8)Emergency spine surgery.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  24 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
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
 
at 24 and 48 hours post operatively 
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 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   23/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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