An interventional study of Dexmeditomidine and Normal saline in Dexmedetomidine, Gastric Emptying and Ultrasound, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the effect of dexmedetomidine on gastric emptying assessed by gastric ultrasound in patients undergoing laparoscopic cholecystectomy.
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.
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).
Drug: Dexmeditomidine
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 (0.2 µg/kg/hr dexmeditomidine).
Also known as: Group D
Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion.
Also known as: Group C
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).
Time frame: 3 hours postoperatively
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.
Time frame: 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).
Time frame: 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.
Time frame: 24 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Tanta University