Gabapentin and Pressor Response to Intubation

NCT06705101 | Not Yet Recruiting Phase 1

• 1 other identifier: 0842-2022-LNH-ERC
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effectiveness of oral gabapentin in reducing the pressor response (increased MAP, HR, and BP) during laryngoscopic intubation. It is a prospective, double-blind randomized controlled trial involving 144 patients undergoing elective surgery. Gabapentin 300 mg or placebo will be administered preoperatively, with hemodynamic parameters monitored before and after intubation. The study aims to determine if gabapentin attenuates the sympathetic stress response compared to placebo.

Conditions

Elective Surgical Patients; Blood Pressure

Keywords

Gabapentin; Laryngoscopy; Hemodynamic Stability; Pressor Response

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Pressure (MAP)

  The primary outcome is the change in MAP before intubation, 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation. The focus is on whether Gabapentin maintains MAP within 20 mmHg of the patient's baseline reading.

  2 minutes, and 5 minutes after laryngoscopy and tracheal intubation

Study Arms (2)

Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment.

EXPERIMENTAL

Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment.

Drug: Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin

Placebo Group (Group P): Participants receiving a placebo as a pre-treatment.

PLACEBO COMPARATOR

Placebo Group (Group P): Participants receiving a placebo as a pre-treatment.

Other: Placebo Oral Tablet

Interventions

Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin DRUG

In this study, the intervention involves administering 300 mg of oral gabapentin to patients in the intervention group two hours prior to surgery, aiming to assess its efficacy in attenuating the pressor response to laryngoscopy and tracheal intubation.

Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment.

Placebo Oral Tablet OTHER

The placebo group will receive an identical capsule without active medication, administered two hours before surgery, to compare its effects with those of gabapentin on the pressor response to laryngoscopy and tracheal intubation.

Placebo Group (Group P): Participants receiving a placebo as a pre-treatment.

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I or II patients (American Society of Anesthesiologists Physical Status Classification).
• Age between 18 and 59 years.
• Scheduled for elective surgery under general anesthesia with endotracheal intubation.

You may not qualify if:

• Anticipated difficult intubation.
• ASA III or greater.
• Patients with hiatus hernia or gastro-esophageal reflux disease (GERD).
• Body weight more than 20% of ideal body weight.
• Patients on antihypertensive drugs, sedatives, hypnotics, or antidepressants.

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

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

Central Study Contacts

AEMAN ZUBAIR Dr, FCPS I

CONTACT

+923332325316

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: December 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 16, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share