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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622618
• Other study ID #: FAMSU R 53/2020
• Status: Completed
• Phase: Early Phase 1
• Start date: September 15, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 15, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea, Postoperative
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting
• Vomiting, Postoperative

Intervention

Drug:
• Gabapentin
Anticonvulsant, Antiemetic, Analgesic

Locations

Country	Name	City	State
Egypt	AinShams University, Faculty of medicine	Cairo	Abbasia
Egypt	AinShams University, Faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PONV episodes (nausea, retching or vomiting)	number of attacks	at H4 (4th hour) postoperative
Primary	Incidence of PONV episodes (nausea, retching or vomiting)	number of attacks	at H12 (12th hour) postoperative
Primary	Incidence of PONV episodes (nausea, retching or vomiting)	number of attacks	at H24 (24th hour) postoperative
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	incidence of side effects	dizziness, headache and somnolence	during the first 24 hours postoperative