Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
Information source: Assiut University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: dexamethasone (Drug); Gabapentin (Drug); Aprepitant (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Assiut University Official(s) and/or principal investigator(s): Hala S Abdel-Ghaffar, MD, Principal Investigator, Affiliation: Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
Overall contact: Hala S Abdel-Ghaffar, MD, Phone: +2 01003812011, Email: hallasaad@yahoo.com
Summary
To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin
prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic
gynacological surgeries.
Clinical Details
Official title: Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: incidence (%) of postoperative nausea and vomiting
Secondary outcome: non invasive blood pressureheart rate side effects
Detailed description:
Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery
room. Laparoscopic surgery is one important risk factor for increased incidence of PONV.
Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some
activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of
gabapentin are conflicting.
Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of
substance P. Substance P is a neurotransmitter found in central areas associated with emesis
such as the dorsal vagal complex and area postrema.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
• ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic
gynacological surgeries under general anesthesia.
Exclusion Criteria:
- Central or peripheral neurological pathologies.
- History of drug abuse, chronic pain, or psychiatric disorders.
- Pregnant women
- Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of
operation.
Locations and Contacts
Hala S Abdel-Ghaffar, MD, Phone: +2 01003812011, Email: hallasaad@yahoo.com
Hala saad Abdel-Ghaffar, Assiut, Assiut governorate 715715, Egypt; Recruiting
Additional Information
Starting date: August 2015
Last updated: August 14, 2015
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