Skip to main content
OpenTrials
Completed

NCT Number: NCT04622618

Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting

Overall incidence of postoperative nausea and vomiting (PONV) after general anesthesia is 40-90 % . gabapentin has been incorporated into "fast-track" packages and improved recovery during surgery protocols to avoid unintended side effects associated with opioid alternatives. Interestingly, gabapentin has also been noted to reduce the effects of chemotherapy-induced nausea, effective in treatment of gravidarum hyperemesis, and postdural puncture emesis. Different dosing regimens were tested.The goal of the study is to determine the most effective dose of oral gabapentin given 1 hour prior to surgery on the occurrence and severity of PONV and drug side effects in the first 24 hours postoperatively to find the most effective dose of gabapentin with the least side effects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

AinShams University, Faculty of medicine, Cairo, Abbasia, Egypt

Loading trial locations.

About this study

A total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (50 patients each(. The first group of patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G1), the second group of patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G2), the third group of patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G3). Drug formulation will be done by one of the researchers making the dosage of the three groups the same in number and shape of the capsules and then given to a junior anesthetist who is neither involved nor interested in any way in the sample to be administered to the patients surveyed

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age between (18- 65) years
  • ASA I-II
  • scheduled for elective laparoscopic abdominal surgery.

Exclusion criteria

  • age below 18 and above 60 years
  • ASA III- IV
  • pregnancy or breastfeeding
  • psychiatric illness
  • administration of antiemetic or systemic corticosteroids within 24 hours prior to surgery
  • vomiting within 24 hours prior to surgery
  • alcohol or drug abuse;
  • known hypersensitivity or contraindications to gabapentin
  • impaired liver or kidney function
  • history of motion sickness
  • patients on anti-depressants
  • patients on whom laparoscopic procedure converted into open technique.

Treatment and study plan

Gabapentin

Drug

Anticonvulsant, Antiemetic, Analgesic

Primary outcomes

  1. Incidence of PONV episodes (nausea, retching or vomiting)

    Time frame: at H4 (4th hour) postoperative

    number of attacks

  2. Incidence of PONV episodes (nausea, retching or vomiting)

    Time frame: at H12 (12th hour) postoperative

    number of attacks

  3. Incidence of PONV episodes (nausea, retching or vomiting)

    Time frame: at H24 (24th hour) postoperative

    number of attacks

  4. Severity of nausea

    Time frame: at H4 (4th hour) postoperative

    measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)

  5. Severity of nausea

    Time frame: at H12 (12th hour) postoperative

    measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)

  6. Severity of nausea

    Time frame: at H24 (24th hour) postoperative

    measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)

Secondary outcomes

  1. Need for rescue antiemetic

    Time frame: during the first 24 hours postoperative

    if severe nausea or two or more emetic episodes, or upon a request from the patient to be repeated if no response within 1 hour up to 3 mg.

  2. Intensity of postoperative pain: Visual Analogue Scale

    Time frame: Total dose in (mg) given during the first 24 hours postoperative

    assessed by using an 11-points Visual Analogue Scale from 0-10 (0= no pain, 10 = worst intolerable pain, mild pain 1-3, moderate pain 4-6, or severe pain 7-10)

  3. incidence of side effects

    Time frame: during the first 24 hours postoperative

    dizziness, headache and somnolence

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting After Abdominal Laparoscopic Surgery: a Randomized Prospective Comparative Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2020
Registry last updated
May 27, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.