Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption

Gabapentin Clinical Trial

Official title:

Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05301205
• Other study ID #: N-48-2021
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: June 25, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: July 30, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gabapentin

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sevoflurane consumption	Intra-operative consumption of sevoflurane will be measured and recorded (ml/hr).	4 hours
Secondary	nalbuphine consumption	postoperative nalbuphine consumption by mg	24 hours
Secondary	Intraoperative fentanyl consumption.	Intraoperative fentanyl consumption by mic	6 hours