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

March 22, 2016 updated by: Hala Saad Abdel-Ghaffar, Assiut University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assiut governorate
      • Assiut, Assiut governorate, Egypt, 715715
        • Hala Saad Abdel-Ghaffar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexamethasone
intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;
Drug: dexamethasone
dexamethasone 8 mg iv 2 minutes before induction of anesthesia
Other Names:
  • Decadron
Active Comparator: gapabentin
oral gabapentin 600 mg 1 hour before induction of anesthesia
Drug: dexamethasone
dexamethasone 8 mg iv 2 minutes before induction of anesthesia
Other Names:
  • Decadron
Drug: Gabapentin
oral gabapentin 600 mg 1 hour before induction of anesthesia
Other Names:
  • Neurontin
Active Comparator: Aprepitant
aprepitan 80mg 1 hour before induction of anesthesia.
Drug: dexamethasone
dexamethasone 8 mg iv 2 minutes before induction of anesthesia
Other Names:
  • Decadron
Drug: Aprepitant
oral aprepitan 80mg 1 hour before induction of anesthesia.
Other Names:
  • Emend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence (%) of postoperative nausea and vomiting
Time Frame: 24 hours postoperative
The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non invasive blood pressure
Time Frame: 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
intra-operative from induction of general anesthesia till end of surgery.
heart rate
Time Frame: 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
Intra-operative from induction of anesthesia till end of surgery.
side effects
Time Frame: 24 h postoperative.
Side effects of given drugs will be treated and recorded
24 h postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008718/ reference no. 104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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