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NCT Number: NCT06634524

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

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

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Key information

Conditions

Dexmedetomidine Gastric Emptying Laparoscopic Cholecystectomy Ultrasound

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmeditomidine

Drug

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

Other names: Group D

normal saline

Drug

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

Other names: Group C

Primary outcomes

  1. Assessment of gastric volume with the aid of ultrasound

    Time frame: 3 hours postoperatively

    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).

Secondary outcomes

  1. Measurement of cross-sectional area of gastric antrum

    Time frame: 3 hours postoperatively

    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.

  2. Gastric content assessment.

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

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

    Time frame: 24 hours postoperatively

    Time of passage of flatus will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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