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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

dexamethasone

Gabapentin

Aprepitant

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Hala saad Abdel-Ghaffar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

dexamethasone

gapabentin

Aprepitant

Arm Description

intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;

oral gabapentin 600 mg 1 hour before induction of anesthesia

aprepitan 80mg 1 hour before induction of anesthesia.

Outcomes

Primary Outcome Measures

incidence (%) of postoperative nausea and vomiting

The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.

Secondary Outcome Measures

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

heart rate

heart rate recorded immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery

side effects

Side effects of given drugs will be treated and recorded

Full Information

NCT ID

NCT02525848

First Posted

August 14, 2015

Last Updated

March 22, 2016

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02525848

Brief Title

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

Acronym

PONV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dexamethasone

Arm Type

Active Comparator

Arm Description

intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;

Arm Title

gapabentin

Arm Type

Active Comparator

Arm Description

oral gabapentin 600 mg 1 hour before induction of anesthesia

Arm Title

Aprepitant

Arm Type

Active Comparator

Arm Description

aprepitan 80mg 1 hour before induction of anesthesia.

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Other Intervention Name(s)

Decadron

Intervention Description

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Other Intervention Name(s)

Neurontin

Intervention Description

oral gabapentin 600 mg 1 hour before induction of anesthesia

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Other Intervention Name(s)

Emend

Intervention Description

oral aprepitan 80mg 1 hour before induction of anesthesia.

Primary Outcome Measure Information:

Title

incidence (%) of postoperative nausea and vomiting

Description

The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

non invasive blood pressure

Description

Noninvasive blood pressure measured immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery

Time Frame

intra-operative from induction of general anesthesia till end of surgery.

Title

heart rate

Description

heart rate recorded immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery

Time Frame

Intra-operative from induction of anesthesia till end of surgery.

Title

side effects

Description

Side effects of given drugs will be treated and recorded

Time Frame

24 h postoperative.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hala S Abdel-Ghaffar, MD

Organizational Affiliation

Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hala saad Abdel-Ghaffar

City

Assiut

State/Province

Assiut governorate

ZIP/Postal Code

715715

Country

Egypt

12. IPD Sharing Statement

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

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