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COMPLETED
NCT07131033
NA

Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy

Sponsor: The Second People's Hospital of Huai'an

View on ClinicalTrials.gov

Summary

Laparoscopic cholecystectomy (LC), although minimally invasive, is frequently associated with postoperative fatigue syndrome (POFS), which can delay recovery and prolong convalescence. Esketamine, an NMDA receptor antagonist, has demonstrated potential benefits in reducing postoperative fatigue and pain through central sensitization blockade and anti-inflammatory effects. Magnesium sulfate, another NMDA receptor antagonist and physiological calcium channel blocker, offers complementary analgesic, anti-inflammatory, and cardiovascular-modulating properties. This randomized, double-blind, 2 × 2 factorial trial aims to evaluate the independent and combined effects of perioperative esketamine and magnesium sulfate on postoperative fatigue, recovery quality, pain, and intraoperative hemodynamics in patients undergoing LC, with the goal of identifying an effective and safe strategy to accelerate early postoperative rehabilitation.

Official title: Effects of Perioperative Intravenous Infusion Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy: A 2×2 Factorial Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2025-09-01

Completion Date

2026-06-01

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

Esketamine

Patients were given intravenous esketamine 0.25 mg/kg 10 min before induction of anaesthesia, followed by continuous pumping at 0.125 mg/(kg-h) until the end of the operation.

DRUG

Magnesium sulfate

Patients were injected with 30 mg/kg of magnesium sulphate intravenously 10 min before the induction of anaesthesia, followed by continuous pumping at 10 mg/(kg-h) until the end of the operation.

DRUG

Esketamine and Magnesium sulfate

Patients received a simultaneous intravenous infusion of esketamine (0.25 mg/kg) and magnesium sulfate (30 mg/kg) over 10 minutes before anesthesia induction, followed by continuous infusion of esketamine at 0.125 mg/kg/h and magnesium sulfate at 10 mg/kg/h via separate channels until surgery completion.

DRUG

Saline

Patients in the control group received an equivalent volume of normal saline infused intravenously over 10 minutes before anesthesia induction, followed by continuous saline infusion at a matched flow rate via a separate channel until surgery completion.

Locations (1)

The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital

Huaian, China