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

Postoperative Nausea and Vomiting Clinical Trial

— PONV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525848
• Other study ID #: IRB00008718/ reference no. 104
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 14, 2015
• Last updated: March 22, 2016
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• dexamethasone
dexamethasone 8 mg iv 2 minutes before induction of anesthesia
• Gabapentin
oral gabapentin 600 mg 1 hour before induction of anesthesia
• Aprepitant
oral aprepitan 80mg 1 hour before induction of anesthesia.

Locations

Country	Name	City	State
Egypt	Hala saad Abdel-Ghaffar	Assiut	Assiut governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence (%) of postoperative nausea and vomiting	The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.	24 hours postoperative	No
Secondary	non invasive blood pressure	Noninvasive blood pressure measured immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery	intra-operative from induction of general anesthesia till end of surgery.	Yes
Secondary	heart rate	heart rate recorded immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery	Intra-operative from induction of anesthesia till end of surgery.	Yes
Secondary	side effects	Side effects of given drugs will be treated and recorded	24 h postoperative.	Yes