Gabapentin and Pressor Response to Intubation

NCT ID: NCT06705101

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-07-16

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.

Detailed Description

Laryngoscopic tracheal intubation often triggers a significant sympathetic response, causing increased heart rate, blood pressure, and other hemodynamic changes, which can pose risks for patients with underlying cardiovascular or cerebrovascular conditions. While various methods and drugs have been employed to mitigate this pressor response, gabapentin-a GABA analog with multimodal effects-has shown promise in reducing such hemodynamic stress. This study aims to evaluate the effectiveness of oral gabapentin as a pretreatment to attenuate the sympathetic response during intubation.

The objective of this study is to compare the effectiveness of gabapentin versus placebo in reducing stress responses, such as mean arterial pressure (MAP), heart rate (HR), and blood pressure (BP), during general anesthesia with endotracheal intubation.

Study Design is Prospective, double-blind, randomized controlled trial and will be conducted in Department of Anesthesia, Liaquat National Hospital.

during 8 months. 144 patients (72 per group), calculated based on prior MAP data, with patients randomized into Gabapentin (Group G) and Placebo (Group P) Patients aged 18-59 years, ASA I or II, undergoing elective surgeries will be included.

Exclusion Criteria is difficult intubation, ASA III or higher, obesity, or use of antihypertensive or sedative drugs.

Participants will receive either 300 mg oral gabapentin or placebo 2 hours before surgery. Standard monitoring and anesthesia protocols will be followed, with blood pressure and heart rate recorded at baseline, 2 minutes, and 5 minutes post-intubation. The primary outcome is MAP, while secondary outcomes include systolic/diastolic BP and HR. Intravenous metoprolol will be administered if required for pressor responses.

SPSS v25 will be used for statistical analysis, with independent t-tests for quantitative data and chi-square tests for categorical variables. A p-value <0.05 will be considered statistically significant.

Hypothesis:

Null: Gabapentin does not attenuate the pressor response. Alternative: Gabapentin attenuates the pressor response.

Rationale:

Gabapentin's potential to modulate sympathetic responses during intubation offers a novel, multimodal approach to anesthesia management. While international studies exist, no local studies have been conducted, making this research vital for assessing its efficacy in the local population.

Conditions

Elective Surgical Patients; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

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

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

Placebo Oral Tablet

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaquat National Hospital & Medical College

OTHER

Sponsor Role: lead

Responsible Party

SYEDA AEMAN ZUBAIR

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

AEMAN ZUBAIR Dr, FCPS I

Role: CONTACT

+923332325316

Other Identifiers

0842-2022-LNH-ERC

Identifier Type: -

Identifier Source: org_study_id