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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT04622618

Collaborator

(none)

150

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea, Postoperative Vomiting, Postoperative Pain, Postoperative	Drug: Gabapentin	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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(.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 (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 15, 2020

Actual Primary Completion Date :

Jan 20, 2021

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of PONV episodes (nausea, retching or vomiting) [at H4 (4th hour) postoperative]
number of attacks
Incidence of PONV episodes (nausea, retching or vomiting) [at H12 (12th hour) postoperative]
number of attacks
Incidence of PONV episodes (nausea, retching or vomiting) [at H24 (24th hour) postoperative]
number of attacks
Severity of nausea [at H4 (4th hour) postoperative]
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)
Severity of nausea [at H12 (12th hour) postoperative]
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)
Severity of nausea [at H24 (24th hour) postoperative]
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.