Clinical trial NCT06634524: Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound in Laparoscopic Cholecystectomy
Official title: The Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound, in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Gastric Emptying
Ultrasound
Laparoscopic Cholecystectomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of gastric volume with the aid of ultrasound
timeFrame: 3 hours postoperatively
Secondary outcomes:
measure: Measurement of cross-sectional area of gastric antrum
timeFrame: 3 hours postoperatively
measure: Gastric content assessment.
timeFrame: 3-hour post-operative marks in post anesthesia care unit (PACU).
measure: Relation between gastric cross-sectional area to time of passage of flatus
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: