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

The Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound, in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Trial.

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

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Laparoscopic Cholecystectomy; Gastric Emptying; Ultrasound
• Intervention / Treatment: Drug: Dexmeditomidine; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmeditomidine group; Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).	Drug: Dexmeditomidine; Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).; Other Names: Group D
Placebo Comparator: Control group; Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion	Drug: Normal saline; Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion.; Other Names: Group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of cross-sectional area of gastric antrum	Gastric ultrasound will be used to measure gastric volume through cross sectional area. Gastric antrum images will be obtained using 2 - 5 MHz curvilinear probe which will be positioned in the sagittal plane of epigastric region. All imaging attempts will be carried out at 2 positions: semi-recumbent and right lateral. Images of gastric antrum will be obtained by identifying the following landmarks - left anterior lobe of the liver anteriorly, inferior vena cava and abdominal aorta posteriorly.	3 hours postoperatively
Gastric content assessment.	We initially will assess the nature (nil, fluid, or solid particles) of the gastric contents. An empty stomach will appear as the antrum walls juxtaposed with a "fat" appearance. The clear fluid will appear as "homogeneously hypoechoic" liquid content without residues. Quantitative assessment of gastric contents will be carried out by measuring the anteroposterior (AP) and craniocaudal (CC) diameters of the gastric antrum 3 times for each ultrasonographic assessment. The mean value of the 3 will be recorded. The universally accepted 2 -diameter -method will be used for the measurement of antrum cross-sectional area (CSA) because it's simple and easy to perform. It will be assessed before induction of anesthesia and at the 1-hour and 3-hour post-operative marks in post anesthesia care unit (PACU).	3-hour post-operative marks in post anesthesia care unit (PACU).
Relation between gastric cross-sectional area to time of passage of flatus	Time of passage of flatus will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: 36264MS663/8/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No