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Completed

NCT Number: NCT02525848

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

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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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hala saad Abdel-Ghaffar

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

dexamethasone 8 mg iv 2 minutes before induction of anesthesia

Other names: Decadron

Gabapentin

Drug

oral gabapentin 600 mg 1 hour before induction of anesthesia

Other names: Neurontin

Aprepitant

Drug

oral aprepitan 80mg 1 hour before induction of anesthesia.

Other names: Emend

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. side effects

    Time frame: 24 h postoperative.

    Side effects of given drugs will be treated and recorded

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: PONV

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2015
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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