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

Ain Shams University

Status and phase: Completed; Early Phase 1

Conditions: Vomiting, Postoperative; Pain, Postoperative; Nausea, Postoperative

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT04622618

FAMSU R 53/2020

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

G 300

Active Comparator group

Description:

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

Treatment:

Drug: Gabapentin

G 600

Active Comparator group

Description:

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

Treatment:

Drug: Gabapentin

G 900

Active Comparator group

Description:

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

Treatment:

Drug: Gabapentin