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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexamethasone

intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

gapabentin

oral gabapentin 600 mg 1 hour before induction of anesthesia

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Gabapentin

Intervention Type DRUG

oral gabapentin 600 mg 1 hour before induction of anesthesia

Aprepitant

aprepitan 80mg 1 hour before induction of anesthesia.

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Aprepitant

Intervention Type DRUG

oral aprepitan 80mg 1 hour before induction of anesthesia.

Interventions

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dexamethasone

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Intervention Type DRUG

Gabapentin

oral gabapentin 600 mg 1 hour before induction of anesthesia

Intervention Type DRUG

Aprepitant

oral aprepitan 80mg 1 hour before induction of anesthesia.

Intervention Type DRUG

Other Intervention Names

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Decadron Neurontin Emend

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No