Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption

Gabapentin, a structural analog of gamma aminobutyric acid (GABA), was introduced within the us as an anticonvulsant, used clinically to treat epilepsy. The drug causes amino acids release within the medulla spinalis dorsal horn and thus decreasing response to neural inputs and stabilizing the nervous activity. The mechanism of action of gabapentin on neuropathic pain is assumed to bind to the alpha 2 delta subunit of the voltage-dependent calcium channel within the central systema nervosum , reducing calcium influx into the nerve terminals and decreases the release of neurotransmitters like glutamate . Gabapentin, therefore, can be used for controlling chronic pain, as in diabetic neuropathy and other neuropathic disorders . Some studies examined the effectiveness of gabapentin for acute postoperative pain management for gynecological surgery, lumbar spinal surgery, arthroplasty, and thoracic surgery . A recent study concluded that gabapentin has a role in preoperative anxiolysis, attenuation of hemodynamic response to intubation, prevention of postoperative nausea and vomiting (PONV) and finally postoperative delirium . Up to date, the effect of preoperative gabapentin on inhaled anesthetic depth is unknown

Study Overview

• Status: Enrolling by invitation
• Conditions: Gabapentin
• Intervention / Treatment: Drug: oral gabapentin

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

1. Inclusion criteria:

   • Patients aged from 18 to 60 years.
   • ASA I-II.
   • Undergoing craniotomy for intracranial tumors.

2. Exclusion criteria:

   • Patient refusal
   • Patients younger than 18 or above 60 years old
   • patients with (ASA) physical status ≥ III
   • patients with compromised cardiovascular, renal, hepatic or neurological function
   • Known allergy to study drug.
   • Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs
   • Suffered from severe psychiatric disease or drug addiction;
   • History of parenteral or oral analgesic intake within the last 48hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group I; will be received oral gabapentin capsule 1200 mg 2h pre-operatively.	Drug: oral gabapentin; will be received oral gabapentin capsule 2 HOURS pre-operatively.
Active Comparator: group II; will be received oral gabapentin capsule 600 mg 2h pre-operatively.	Drug: oral gabapentin; will be received oral gabapentin capsule 2 HOURS pre-operatively.
No Intervention: Group III; will be received placebo capsules at 2 hours preoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sevoflurane consumption	Intra-operative consumption of sevoflurane will be measured and recorded (ml/hr).	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nalbuphine consumption	postoperative nalbuphine consumption by mg	24 hours
Intraoperative fentanyl consumption.	Intraoperative fentanyl consumption by mic	6 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Anticipated): June 13, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: N-48-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: still working

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No