Gabapentin and Pressor Response to Intubation
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-59
SponsorLiaquat National Hospital & Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin
DrugIn 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 Oral Tablet
Other interventionThe 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.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment.Experimental treatment 1 intervention
Group B: Placebo Group (Group P): Participants receiving a placebo as a pre-treatment.Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
2 minutes, and 5 minutes after laryngoscopy and tracheal intubationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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