Last updated: August 26, 2023
Sponsor: Tanta University
Overall Status: Active - Recruiting
Phase
2
Condition
Vomiting
Lactose Intolerance
Colic
Treatment
Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .
Ondansetron 4mg + dexamethasone 8mg + normal saline.
Clinical Study ID
NCT06017167
PONV after lap cholecystectomy
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 70 Female patients aged between 18 and 65 years
- ASA I or II
- patients scheduled for elective laparoscopic cholecystectomy surgery will be includedin this study.
Exclusion
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 beforesurgery.
Study Design
Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Ondansetron 4mg + dexmedetomidine 0.5 ug/kg + normal saline .
Phase: 2
Study Start date:
September 15, 2022
Estimated Completion Date:
October 31, 2023
Study Description
Connect with a study center
Tanta University hospitals
Tanta, Algharbia 31511
EgyptActive - Recruiting
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