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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02525848
Acronym
PONV
Enrollment
150
Registered
2015-08-18
Start date
2015-08-31
Completion date
2016-03-31
Last updated
2016-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

DRUGdexamethasone

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

DRUGGabapentin

oral gabapentin 600 mg 1 hour before induction of anesthesia

DRUGAprepitant

oral aprepitan 80mg 1 hour before induction of anesthesia.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
incidence (%) of postoperative nausea and vomiting24 hours postoperativeThe incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.

Secondary

MeasureTime frameDescription
non invasive blood pressureintra-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
heart rateIntra-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
side effects24 h postoperative.Side effects of given drugs will be treated and recorded

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026