Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

PONV after lap cholecystectomy

The aim of the study is to compare antiemetic effects between dexmedetomidine and ondansteron in the first group versus dexamethasone and ondansteron in the second group. The primary outcome in this study is incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy. The secondary outcomes are: * The severity of post operative nausea and vomiting. * Use of rescue antiemetic drugs. * Postoperative pain and sedation.

2022-09-15

2023-09-01

2023-10-01

Recruiting

Early phase I

70

Inclusion Criteria: * 70 Female patients aged between 18 and 65 years * ASA I or II * patients scheduled for elective laparoscopic cholecystectomy surgery will be included in this study. Exclusion Criteria: * Females above 65 years old. * patients under 18 years old. * ASA \> II. * Obesity (BMI\>40 kgm2). * Known hypersensitivity to drugs used in the study protocol. * Comorbidities that were known to increase the risk of PONV (e.g. vestibular disease). * Liver or renal dysfunction (liver enzyme or creatinine 1.5 times higher than normal). * Alcoholism or drug abuse. * Use of antiemetics and psychotropic drugs or glucocorticoids within 24 h before surgery.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly classified with computer generated random numbers into two equal groups (each group 35 patients) Group I: will receive Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline to complete 10 ml. volume IV infusion over 10 minutes.\n\nGroup II: will receive Ondansetron 4mg + dexamethasone 8mg + normal saline to complete 10 ml volume IV ifusion over 10 minutes.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double (Participant, Outcomes Assessor)\n\n* The participants will be kept blind in both groups.\n* Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2023-08-30