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

Primary Purpose

Nausea, Postoperative, Vomiting, Postoperative, Pain, Postoperative

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea, Postoperative focused on measuring gabapentin, postoperative nausea and vomiting, laparoscopic surgeries, Visual analogue scale

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • AinShams University, Faculty of medicine
  • AinShams University, Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

G 300

G 600

G 900

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence of PONV episodes (nausea, retching or vomiting)
number of attacks
Incidence of PONV episodes (nausea, retching or vomiting)
number of attacks
Incidence of PONV episodes (nausea, retching or vomiting)
number of attacks
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)
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)
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)

Secondary Outcome Measures

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.
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)
incidence of side effects
dizziness, headache and somnolence

Full Information

First Posted
October 2, 2020
Last Updated
May 26, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04622618
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Postoperative, Vomiting, Postoperative, Pain, Postoperative
Keywords
gabapentin, postoperative nausea and vomiting, laparoscopic surgeries, Visual analogue scale

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G 300
Arm Type
Active Comparator
Arm Description
The patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water
Arm Title
G 600
Arm Type
Active Comparator
Arm Description
The patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water
Arm Title
G 900
Arm Type
Active Comparator
Arm Description
The patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Anticonvulsant, Antiemetic, Analgesic
Primary Outcome Measure Information:
Title
Incidence of PONV episodes (nausea, retching or vomiting)
Description
number of attacks
Time Frame
at H4 (4th hour) postoperative
Title
Incidence of PONV episodes (nausea, retching or vomiting)
Description
number of attacks
Time Frame
at H12 (12th hour) postoperative
Title
Incidence of PONV episodes (nausea, retching or vomiting)
Description
number of attacks
Time Frame
at H24 (24th hour) postoperative
Title
Severity of nausea
Description
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)
Time Frame
at H4 (4th hour) postoperative
Title
Severity of nausea
Description
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)
Time Frame
at H12 (12th hour) postoperative
Title
Severity of nausea
Description
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)
Time Frame
at H24 (24th hour) postoperative
Secondary Outcome Measure Information:
Title
Need for rescue antiemetic
Description
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.
Time Frame
during the first 24 hours postoperative
Title
Intensity of postoperative pain: Visual Analogue Scale
Description
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)
Time Frame
Total dose in (mg) given during the first 24 hours postoperative
Title
incidence of side effects
Description
dizziness, headache and somnolence
Time Frame
during the first 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
AinShams University, Faculty of medicine
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11591
Country
Egypt
Facility Name
AinShams University, Faculty of medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Excel sheets of the study
IPD Sharing Time Frame
12 months
IPD Sharing Access Criteria
editors of the journal to be submitted to or the corresponding author
IPD Sharing URL
http://gharabawy76@yahoo.com

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

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