Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries

Phase 2

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: dexamethasone; Drug: Aprepitant; Drug: Gabapentin

• Registration Number: NCT02525848
• Lead Sponsor: Assiut University

Brief 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.

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant	dexamethasone	aprepitan 80mg 1 hour before induction of anesthesia.
Aprepitant	Aprepitant	aprepitan 80mg 1 hour before induction of anesthesia.
dexamethasone	dexamethasone	intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;
gapabentin	dexamethasone	oral gabapentin 600 mg 1 hour before induction of anesthesia
gapabentin	Gabapentin	oral gabapentin 600 mg 1 hour before induction of anesthesia

Primary Outcome Measures

Name	Time	Method
incidence (%) of postoperative nausea and vomiting	24 hours postoperative	The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.

Secondary Outcome Measures

Name	Time	Method
non invasive blood pressure	intra-operative from induction of general anesthesia till end of surgery.	Noninvasive blood pressure measured immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery
heart rate	Intra-operative from induction of anesthesia till end of surgery.	heart rate recorded immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery
side effects	24 h postoperative.	Side effects of given drugs will be treated and recorded

Trial Locations

Locations (1)

Hala saad Abdel-Ghaffar; 🇪🇬 Assiut, Assiut governorate, Egypt