Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption

NCT05301205 | Unknown Early Phase 1 DMC

• 1 other identifier: N-48-2021
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gabapentin

Outcome Measures

Primary Outcomes (1)

• sevoflurane consumption

  Intra-operative consumption of sevoflurane will be measured and recorded (ml/hr).

  4 hours

Secondary Outcomes (2)

• nalbuphine consumption

  24 hours

• Intraoperative fentanyl consumption.

  6 hours

Study Arms (3)

group I

ACTIVE COMPARATOR

will be received oral gabapentin capsule 1200 mg 2h pre-operatively.

Drug: oral gabapentin

group II

ACTIVE COMPARATOR

will be received oral gabapentin capsule 600 mg 2h pre-operatively.

Drug: oral gabapentin

Group III

NO INTERVENTION

will be received placebo capsules at 2 hours preoperatively.

Interventions

oral gabapentin DRUG

will be received oral gabapentin capsule 2 HOURS pre-operatively.

group I; group II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Gabapentin

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: March 29, 2022
• Study Start: June 25, 2021
• Primary Completion: June 13, 2023
• Study Completion: July 30, 2023
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

EG (1)