A study comparing effects of two drugs ie., melatonin and midazolam which are given orally before surgery for relieving anxiety in children undergoing surgery

Not yet recruiting

Conditions: Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: N471||Phimosis, (3) ICD-10 Condition: L598||Other specified disorders of the skin and subcutaneous tissue related to radiation,

Registration Number: CTRI/2020/06/025698

Lead Sponsor: ESIC MEDICAL COLLEGE

Brief Summary: 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 childâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

ASA 1 AND 2 SHEDULED FOR ELECTIVE SURGERY INFORMED WRITTEN CONSENT.

Exclusion Criteria

1.ASA 3 AND 4 2.PATIENT WHO HAD TAKEN BENZODIAZEPIINES,OPIOD DRUGS AND OTHER SEDATIVES IN PREVIOUS MONTH 3.PATIENT REFUSAL 4.PATIENT UNDERGOING EMERGENCY SURGERY.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedation and anxiety scores after premedication.	Just before premedication. \| 90 minutes after premedication. \| Before induction. \| 10minutes after extubation.
Induction dose of propofol	Just before premedication. \| 90 minutes after premedication. \| Before induction. \| 10minutes after extubation.

Secondary Outcome Measures

Name	Time	Method
INDUCTION DOSE OF PROPOFOL	After loss of eyelash reflex

Trial Locations

Locations (1): ESIC MEDICAL COLLEGE
🇮🇳
Hyderabad, TELANGANA, India
ESIC MEDICAL COLLEGE
🇮🇳Hyderabad, TELANGANA, India
R DEVI SAI PRIYANKA
Principal investigator
9440483910
rdspriyanka@gmail.com