Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound in Laparoscopic Cholecystectomy

NCT ID: NCT06634524

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-12
• Study Completion Date: 2025-03-01

Brief Summary

The aim of this study is to evaluate the effect of dexmedetomidine on gastric emptying assessed by gastric ultrasound in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Delayed return of normal gastrointestinal function, and postoperative nausea and vomiting (PONV) are common adverse events of laparoscopic cholecystectomy under general anesthesia. Sympathetic stimulation, intra-abdominal carbon dioxide insufflation, and the consequent visceral peritoneal irritation are all contributing factors. In addition, anesthetic agents and opioids can also have a harmful impact on gastric emptying.

Dexmedetomidine, a potent and highly selective alpha-2 adrenoreceptor agonist, is frequently employed as an anesthetic adjunct in surgical procedures. By reducing the surgical stress response through its central sympatholytic and anti-inflammatory effects, dexmedetomidine offers distinct organ protection. Furthermore, its opioid-sparing effect reduces the need for perioperative analgesics.

A recent meta-analysis reported a positive impact of perioperative dexmedetomidine use on postoperative gastrointestinal function by shortening the time to pass flatus.The use of gastric ultrasound to assess cross-sectional area of the stomach and it's volume may provide better insight into the effect of dexmedetomidine on gastrointestinal function.

Conditions

Dexmedetomidine; Gastric Emptying; Ultrasound; Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmeditomidine group

Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).

Group Type: EXPERIMENTAL

Dexmeditomidine

Intervention Type: DRUG

Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).

Control group

Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion.

Interventions

Dexmeditomidine

Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).

Intervention Type: DRUG

Normal saline

Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion.

Intervention Type: DRUG

Other Intervention Names

Group D; Group C

Eligibility Criteria

Inclusion Criteria

• Patients aged 21 to 65 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Undergoing elective laparoscopic cholecystectomy surgery

Exclusion Criteria

• Patient's refusal.
• Patients with abnormalities in gastrointestinal tracts (including previous esophageal or gastric surgery, tumors or stricture).
• Failure to follow preoperative fasting guidelines.
• Patients with a body mass index ≥ 35
• Patients on regular treatment of antacids or prokinetic.
• Presence of history of disease causing an increase in the incidence of delayed gastric emptying such as: diabetes mellitus, obesity or electrolyte disturbances.
• Pregnancy.
• Presence of hepatic or renal dysfunction.
• Presence of existing condition causing bradycardia such as heart block, or patients on regular calcium channel blockers or beta blockers.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Noran Hesham Mohammed Elsaid Borg

Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Tanta, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264MS663/8/24

Identifier Type: -

Identifier Source: org_study_id