Clinical trial NCT04622618: Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting
Official title: Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting After Abdominal Laparoscopic Surgery: a Randomized Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Nausea, Postoperative
Vomiting, Postoperative
Pain, Postoperative
Keywords: gabapentin
postoperative nausea and vomiting
laparoscopic surgeries
Visual analogue scale
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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(.
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of PONV episodes (nausea, retching or vomiting)
timeFrame: at H4 (4th hour) postoperative
measure: Incidence of PONV episodes (nausea, retching or vomiting)
timeFrame: at H12 (12th hour) postoperative
measure: Incidence of PONV episodes (nausea, retching or vomiting)
timeFrame: at H24 (24th hour) postoperative
measure: Severity of nausea
timeFrame: at H4 (4th hour) postoperative
measure: Severity of nausea
timeFrame: at H12 (12th hour) postoperative
measure: Severity of nausea
timeFrame: at H24 (24th hour) postoperative
Secondary outcomes:
measure: Need for rescue antiemetic
timeFrame: during the first 24 hours postoperative
measure: Intensity of postoperative pain: Visual Analogue Scale
timeFrame: Total dose in (mg) given during the first 24 hours postoperative
measure: incidence of side effects
timeFrame: during the first 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University, Faculty of medicine
state: Abbasia
city: Cairo
country: Egypt
facility: AinShams University, Faculty of medicine
Study officials:
References: