Effect of Esmolol on Recovery after Spine Surgery under General Anaesthesia

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 - QuaRELS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103668

Enrollment

Registered

2026-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 fixati

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 24 hours after surgery.	—

Secondary

Measure	Time frame
QoR-15 scoreTimepoint: at 48 h post operatively;Difference in individual domains of QoR-15 scoreTimepoint: at 24 and 48 hours;Cumulative post operative opioid consumption in iv morphine equivalents Timepoint: at 24 and 48 hours post operatively;Difference in intraoperative fentanyl requirementsTimepoint: Intraoperative period;Difference in hemodynamic responseTimepoint: At 3 min after intubation and 3 min after extubation;Difference in frequency of hypotensive episodeTimepoint: Intraoperative period	—

Measure

Time frame

QoR-15 scoreTimepoint: at 48 h post operatively;Difference in individual domains of QoR-15 scoreTimepoint: at 24 and 48 hours;Cumulative post operative opioid consumption in iv morphine equivalents Timepoint: at 24 and 48 hours post operatively;Difference in intraoperative fentanyl requirementsTimepoint: Intraoperative period;Difference in hemodynamic responseTimepoint: At 3 min after intubation and 3 min after extubation;Difference in frequency of hypotensive episodeTimepoint: Intraoperative period

—

Countries

India

Contacts

Public ContactProf Dr Satyajeet Misra

All India Institute of Medical Sciences, Bhubaneswar

misrasatyajeet@gmail.com9438884048

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026