A comparitive study on effects of oral melatonin versus oral midazolam as premedicant in children undergoing surgery under general anesthesia

Pre-operative anxiety in children is associated with adverse post-operative outcomes, such as increased distress in the recovery phase, and post-operative regressive behavioural disturbances, such as nightmares, separation anxiety, eating disorders and bedwetting. Allaying this anxiety is of utmost importance for providing a calm and pleasant anaesthetic experience and preventing an adverse impact on the psychological milieu of the child in the future.  Benzodiazepines, mainly midazolam are the most commonly used pre-medicants to decrease anxiety.They can cause delayed recovery from anaesthesia, cognitive and psychomotor impairement.Melatonin and its analogues differ from benzodiazepines by exerting a sleep promoting effect by amplifying day/night differences in alertness and sleep quality and by displaying a modest and quite mild sleep inducing effect.                                      Melatonin has been proposed as alternative to midazolam as a premedication in procedures preceding anesthesia induction.Primary objective is to evaluate the efficacy of oral melatonin on preoperative anxiety and sedation in children undergoing surgery.Effect of melatonin premedication on the required induction dose of propofol in comparision to midazolam and postoperative sedation is also assessed in both groups.

This study will be conducted in the Department of Anesthesiology at ESIC medical college  and super speciality hospital, sanath nagar, hyderabad and  over a period of 6 months from October 2019 to march 2020 after obtaining approval from the institutional ethical  committee.

A total of 70 cases of ASA I and II physical status,belonging to either sex;between ages of 2-10years scheduled for elective surgeries under  general anesthesia will be included in the study.

Patients will be randomly assigned to 2 groups based on computer generated random number sequence whether they will receive 0.2 mg/kg (max 5 mg) oral melatonin premedication (group A) or 0.5 mg/kg (max 20 mg) oral midazolam premedication (group B) before induction anaesthesia with propofol.

Approximately 90 minutes before the induction of general anaesthesia, patients will be transported in a quiet room where they will receive melatonin or midazolam syrup orally by a resident not involved in the study.

The child’s level of sedation and anxiety will be assessed and recorded  before the premedication and 90 minutes after the administration of melatonin or midazolam, using the University of Michigan Sedation Scale (UMSS) which has a score of 0-4 and modified Visual Analogue Scale(VAS) which has a score of 0-10 respectively.

The total dose of propofol administrated will be recorded by the anaesthetist blinded to premedication group assignment.To provide objective information on the physical condition of patients after anaesthesia,University of Michigan Sedation Scale  will be calculated after 10 min from conclusion of anesthesia.