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

NCT04622618 | Completed Early Phase 1 DMC

• 1 other identifier: FAMSU R 53/2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Nausea, Postoperative; Vomiting, Postoperative; Pain, Postoperative

Keywords

gabapentin; postoperative nausea and vomiting; laparoscopic surgeries; Visual analogue scale

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Need for rescue antiemetic

  during the first 24 hours postoperative

• Intensity of postoperative pain: Visual Analogue Scale

  Total dose in (mg) given during the first 24 hours postoperative

• incidence of side effects

  during the first 24 hours postoperative

Study Arms (3)

G 300

ACTIVE COMPARATOR

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

Drug: Gabapentin

G 600

ACTIVE COMPARATOR

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

Drug: Gabapentin

G 900

ACTIVE COMPARATOR

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

Drug: Gabapentin

Interventions

Gabapentin DRUG

Anticonvulsant, Antiemetic, Analgesic

G 300; G 600; G 900

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between (18- 65) years
• ASA I-II
• scheduled for elective laparoscopic abdominal surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

AinShams University, Faculty of medicine

Cairo, Abbasia, 11591, Egypt

Location

AinShams University, Faculty of medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, Intensive care and pain management

Model Details: 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(.

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: November 10, 2020
• Study Start: September 15, 2020
• Primary Completion: January 20, 2021
• Study Completion: February 15, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months
• Access Criteria: editors of the journal to be submitted to or the corresponding author

Locations

EG (2)