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

NCT06634524 | Completed

• 1 other identifier: 36264MS663/8/24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Gastric Emptying; Ultrasound; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Assessment of gastric volume with the aid of ultrasound

  Gastric ultrasound will be used to measure gastric volume through cross-sectional area before induction, and 1 and 3 hours postoperatively. Estimated gastric volumes will be calculated using a previously validated formula: gastric volume (mL) = 27.0 + (14.6 ×CSA) - (1.28 ×Age).

  3 hours postoperatively

Secondary Outcomes (3)

• Measurement of cross-sectional area of gastric antrum

  3 hours postoperatively

• Gastric content assessment.

  3-hour post-operative marks in post anesthesia care unit (PACU).

• Relation between gastric cross-sectional area to time of passage of flatus

  24 hours postoperatively

Study Arms (2)

Dexmeditomidine group

EXPERIMENTAL

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

Drug: Dexmeditomidine

Control group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Dexmeditomidine DRUG

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

Also known as: Group D

Dexmeditomidine group

Normal saline DRUG

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

Also known as: Group C

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 12, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)