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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-02-15

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Nausea, Postoperative Vomiting, Postoperative Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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. Patients will be divided randomly and equally into three groups (50 patients each(.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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. Blind grouping will be kept to all including the patients themselves, until the completion of the study. Data collection will be done by another anesthesiologist who is blinded to the given medication during the study and not included in the research team.

Study Groups

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G 300

The patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Anticonvulsant, Antiemetic, Analgesic

G 600

The patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Anticonvulsant, Antiemetic, Analgesic

G 900

The patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Anticonvulsant, Antiemetic, Analgesic

Interventions

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Gabapentin

Anticonvulsant, Antiemetic, Analgesic

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes