NCT06838650

Beneficial Effects of Low-Dose Intravenous Dexmedetomidine Premedication in Patient Undergoing Laparoscopic Cholecystectomy Under General Anesthesia

Not yet recruiting Phase 3 Last updated 21 February 2025

What this trial tests

Phase 3 trial testing Dexmedetomidine in Laparoscopic Cholecystectomy Surgery in 100 participants. Not yet recruiting.

Timeline

1 March 2025

Primary endpoint
1 May 2026

1 June 2026

Quick facts

Lead sponsor	Assiut University
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 March 2025
Primary completion	1 May 2026
Estimated completion	1 June 2026

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Saline

Conditions studied

• Laparoscopic Cholecystectomy Surgery — all drugs for Laparoscopic Cholecystectomy Surgery →

Sponsor

Assiut University

Who can join

Adults 18 to 64, any sex, with Laparoscopic Cholecystectomy Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Laparoscopic cholecystectomy (LC) is considered the standard treatment for gallbladder disease.1 Compared to open cholecystectomy, LC is the preferred treatment approach because it is associated with less surgical trauma, shorter hospital stays, and faster postoperative recovery.2 However, the elevated intra-abdominal pressure due to pneumoperitoneum can cause various stress responses that affect patient prognosis and present a severe challenge in anesthetic management.3 Therefore, the search for an optimal anesthetic protocol to minimize adverse reactions during LC remains critical.

Dexmedetomidine (Dex), a potent and highly selective α2-adrenergic receptor agonist, presents sedative, analgesic, anesthetic, and sympatholytic properties, without causing respiratory depression, when used in an appropriate dose range.4 Numerous studies have suggested that Dex can effectively attenuate the surgical stress response and provide intraoperative hemodynamic stability.5 Furthermore, it has been shown to reduce anesthetic requirements and improve the quality of patient recovery.6,7 Hence, it has been widely used as an adjuvant during general anesthesia.

Nevertheless, the clinical effects of Dex remain controversial. Some studies have shown that the anesthesia recovery time is prolonged and the incidence of bradycardia increases significantly after intravenous Dex infusion.8-10 This is mainly attributed to the different doses and methods of Dex administration. Although the complications are always transient and reversible, timely attention is required to avoid serious adverse consequences. To enhance the value of Dex for clinical application and improve the quality of general anesthesia, the more appropriate protocol of Dex administra- tion need to be explored. The elimination half-life of Dex is approximately 2 h, with a rapid distribution half-life of approximately 6 min.11 Most LC procedures are completed within 1 h; therefore, to reduce postoperative complications and shorten postoperative recovery time, we prefer preoperative Dex loading to intraoperative continuous Dex infusion. According to our previous data, the anesthesia awakening time will be prolonged and the incidence of bradycardia increased significantly when 1.0 µg/kg of Dex will be administered before general anesthesia induction. This prospective, double-blind, randomized controlled trial aimed to determine the efficacy of low-dose (0.5 µg/kg) intravenous Dex premedication on hemodynamics and adverse events during general anesthesia. We aimed to confirm the efficacy of low- dose intravenous Dex premedication in patients under general anesthesia during LC and to provide a data reference for the clinical application of Dex in further research. Dexmedetomidine (Dex) is a potent and highly selective α2-adrenergic receptor agonist. Within an appropriate dose range, Dex can effectively attenuate the surgical stress response, provide intraoperative hemodynamic stability, and improve the patient recovery quality. High-dose Dex can delay patient awakening from anesthesia and increase the incidence of bradycardia. This randomized controlled trial aimed to investigate the effects of low-dose intravenous Dex premedication in patients undergoing laparoscopic cholecystectomy (LC).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.