Comparative Evaluation of Oral Melatonin versus Oral Alprazolam as Premedication in Patients Undergoing Tympanoplasty: A Randomised Control Study

Introduction: Preoperative anxiety is commonly experienced by patients who are admitted to hospital for any surgery and the role of premedication becomes important from an anaesthetist’s point of view, to relieve anxiety, provide sedation and ensure adequate analgesia. Aim: To compare the effects of oral melatonin versus oral alprazolam as premedication and their impact on postoperative recovery characteristics in patients undergoing tympanoplasty. Materials and Methods: In this randomised controlled study which was conducted from August 2022 to March 2024 at the Department of Anaesthesiology, School of Medical Sciences and Research, Sharda University, Greater Noida, Uttar Pradesh, India, a total of 70 adult patients were randomly allocated into two groups. Group M (n=35) received oral melatonin 6 mg and group A (n=35) received oral alprazolam 0.50 mg 120 minutes before surgery. The objectives of the study were to compare anxiety, sedation, cognition and pain using the Visual Analogue Scale (VAS), Ramsay Sedation Score (RSS), Digit Symbol Substitution Test (DSST) score and Numerical Rating Scale (NRS), respectively. The Shapiro-Wilk test, Independent t-test, Chi-square test and Fisher’s-exact test were used for statistical analysis. Results: The age distribution, gender, body mass index, American Society of Anaesthesiologists (ASA) status and mean duration of surgery were comparable between the two groups. Mean VAS scores were significantly lower in group M at 60 minutes (3.03±1.29 vs 3.77±1.21) and at 120 minutes (2.17±1.12 vs 2.91±1.12). Even in the postoperative period, compared to group A, the VAS score was lower in group M after extubation at various time intervals. RSS scores were lower in group M compared to group A at 60 minutes and at 120 minutes of drug administration. In the postoperative period, compared to group A, group M had lower sedation scores after extubation at 30 minutes, 60 minutes, 90 minutes and 120 minutes (p-value <0.0001). Compared to group A, group M had statistically significantly higher DSST scores at various time intervals in both the preoperative and postoperative periods (p-value <0.0001). group M had significantly lower NRS scores after extubation at various time intervals (p-value <0.0001) compared to group A, indicating that pain was significantly lower in the postoperative period with the use of melatonin. Conclusion: Oral melatonin (6 mg) is shown to be an effective alternative to alprazolam (0.5 mg) as a premedication. Oral melatonin offered superior anxiolysis while inducing less sedation compared to alprazolam. In addition, there was better preservation of cognitive function with melatonin compared to alprazolam.