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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Nausea, Postoperative; Vomiting, Postoperative
• Intervention / Treatment: Drug: Gabapentin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • AinShams University, Faculty of medicine
  • Abbasia
    • Cairo, Abbasia, Egypt, 11591
      • AinShams University, Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: G 300; The patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water	Drug: Gabapentin; Anticonvulsant, Antiemetic, Analgesic
Active Comparator: G 600; The patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water	Drug: Gabapentin; Anticonvulsant, Antiemetic, Analgesic
Active Comparator: G 900; The patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water	Drug: Gabapentin; Anticonvulsant, Antiemetic, Analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of PONV episodes (nausea, retching or vomiting)	number of attacks	at H4 (4th hour) postoperative
Incidence of PONV episodes (nausea, retching or vomiting)	number of attacks	at H12 (12th hour) postoperative
Incidence of PONV episodes (nausea, retching or vomiting)	number of attacks	at H24 (24th hour) postoperative
Severity of nausea	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)	at H4 (4th hour) postoperative
Severity of nausea	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)	at H12 (12th hour) postoperative
Severity of nausea	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)	at H24 (24th hour) postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for rescue antiemetic	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.	during the first 24 hours postoperative
Intensity of postoperative pain: Visual Analogue Scale	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)	Total dose in (mg) given during the first 24 hours postoperative
incidence of side effects	dizziness, headache and somnolence	during the first 24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: gabapentin; postoperative nausea and vomiting; Visual analogue scale; laparoscopic surgeries
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: FAMSU R 53/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Excel sheets of the study
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: editors of the journal to be submitted to or the corresponding author
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No