Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption

Sponsor
Cairo University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05301205
Collaborator
(none)
96
1
3
25.1
3.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: oral gabapentin
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption
Actual Study Start Date :
Jun 25, 2021
Anticipated Primary Completion Date :
Jun 13, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. sevoflurane consumption [4 hours]

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

Secondary Outcome Measures

  1. nalbuphine consumption [24 hours]

    postoperative nalbuphine consumption by mg

  2. Intraoperative fentanyl consumption. [6 hours]

    Intraoperative fentanyl consumption by mic

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  1. Inclusion criteria:
  • Patients aged from 18 to 60 years.

  • ASA I-II.

  • Undergoing craniotomy for intracranial tumors.

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Cairo Egypt 11562

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University
ClinicalTrials.gov Identifier:
NCT05301205
Other Study ID Numbers:
  • N-48-2021
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022