SAFETY AND SIDE-EFFECT PROFILE OF ORAL PREGABALIN AND MELATONIN PREMEDICATION FOR LARYNGOSCOPY AND INTUBATION: A RANDOMIZED CONTROLLED TRIAL
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Keywords
pregabalin; melatonin; laryngoscopy; intubation; haemodynamic response; premedication.
Abstract
Background: Laryngoscopy and endotracheal intubation trigger sympathetic surges that can be hazardous in susceptible patients. Pregabalin and melatonin are attractive oral premedicants with potential to blunt these responses.
Objective: To compare the safety and side-effect profile of oral pregabalin (150 mg) and melatonin (6 mg) with placebo in elective surgical patients undergoing general anaesthesia.
Methods: In this randomized, parallel-group trial conducted at a tertiary centre, 90 ASA I–II adults (18–65 years) scheduled for surgeries >30 min under general anaesthesia were allocated to pregabalin 150 mg, melatonin 6 mg, or placebo, administered orally 120 min pre-induction. Standardized anaesthesia was used. Primary outcomes were haemodynamic responses (HR, SBP, DBP, MAP) at baseline, induction, and 1/3/5/10 min after intubation. Safety/side-effect profile included SpO₂ trends, postoperative pain (VAS), and sedation (Ramsay score), with adverse effects monitored. Analysis used ANOVA.
Results: Groups were comparable in demographics/ASA/Mallampati. Compared with placebo, both pregabalin and melatonin significantly attenuated HR, SBP, DBP, and MAP elevations at induction and at 1–10 min post-intubation (all p < 0.0001). Melatonin showed stable haemodynamics at all time points; pregabalin showed early attenuation with return toward baseline by 5–10 min. SpO₂ remained comparable across groups. VAS pain scores were lower with pregabalin and melatonin vs placebo (p < 0.0001). Sedation was higher with pregabalin vs melatonin/placebo (p < 0.0001). No clinically important adverse events were observed; sedation with pregabalin was considered acceptable.
Conclusion: Oral pregabalin (150 mg) and melatonin (6 mg) are safe and effective premedicants for blunting pressor responses to laryngoscopy and intubation; pregabalin yields greater sedation, while melatonin maintains haemodynamic stability with minimal sedative effect.
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Dr. Aasim Ahmad Ahangar
Department of Anaesthesiology and Critical Care ASCOMS, Jammu, J&K, India
Dr. Arshid Rasool Wani
Department of Anaesthesiology and Critical Care ASCOMS, Jammu, J&K, India
Dr Syed Faheem Maqbool
Department of Anaesthesiology and Critical Care ASCOMS, Jammu, J&K, India