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

T

Tanta University

Status

Completed

Conditions

Gastric Emptying
Laparoscopic Cholecystectomy
Dexmedetomidine
Ultrasound

Treatments

Drug: Dexmeditomidine
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06634524
36264MS663/8/24

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

Dexmeditomidine group
Experimental group
Description:
Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).
Treatment:
Drug: Dexmeditomidine
Control group
Placebo Comparator group
Description:
Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Central trial contact

Noran H Borg, MBBCh

Data sourced from clinicaltrials.gov

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