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

Study Overview
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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.

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

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

Conditions
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Nausea, Postoperative, Vomiting, Postoperative, Pain, Postoperative

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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. Patients will be divided randomly and equally into three groups (50 patients each(.
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gabapentin, postoperative nausea and vomiting, laparoscopic surgeries, Visual analogue scale