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

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Gabapentin; Drug: dexamethasone; Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT02525848

IRB00008718/ reference no. 104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

dexamethasone

Active Comparator group

Description:

intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia;

Treatment:

Drug: dexamethasone

gapabentin

Active Comparator group

Description:

oral gabapentin 600 mg 1 hour before induction of anesthesia

Treatment:

Drug: dexamethasone

Drug: Gabapentin

Aprepitant

Active Comparator group

Description:

aprepitan 80mg 1 hour before induction of anesthesia.

Treatment:

Drug: Aprepitant

Drug: dexamethasone