| 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
|
|
|
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
|
|
|
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. |