PDF of Trial CTRI Website URL

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 16:26:24 GMT)

CTRI Number CTRI/2020/06/025698 [Registered on: 08/06/2020] - Trial Registered Prospectively Last Modified On 02/06/2020 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Surgical/Anesthesia Preventive Behavioral Study Design Randomized, Parallel Group Trial Public Title of Study A study comparing effects of two drugs ie., melatonin and midazolam which are given orally before surgery for relieving anxiety in children undergoing surgery Scientific Title of A comparitive study on effects of oral melatonin versus oral midazolam as premedicant in children Study undergoing surgery under general anesthesia Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name R DEVI SAI PRIYANKA Trial Coordinator (multi-center study) Designation DNB RESIDENT Affiliation ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL Address Department of anesthesiology; ESIC medical college and superspeciality hospital,sanathnagar,hyderabad Department of anesthesiology,ESIC Medical college and superspeciality hospital,Sanath nagar,Hyderabad Hyderabad TELANGANA 500018 India Phone 9440483910 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr GSUNANDA Query) Designation Assistant Professor Affiliation Esi medical college and hospital Address Department of anesthesiology,ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL, SANATH NAGAR, HYDERABAD Deparment of anesthesiology,ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL, SANATH NAGAR Hyderabad TELANGANA 500018 India Phone 9866999244 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr GSUNANDA Designation Assistant Professor Affiliation Esi medical college and hospital

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Address Department of anestesiology,ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL, SANATH NAGAR, HYDERABAD Department of anesthesiology,ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL, SANATH NAGAR Hyderabad TELANGANA 500018 India Phone 9866999244 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL,Sanathnagar,Hyderabad,Telangana,500018 Primary Sponsor Primary Sponsor Details Name ESIC MEDICAL COLLEGE Address ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL,SANATH NAGAR,HYDERABAD,TELANGANA Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator R DEVI SAI PRIYANKA ESIC MEDICAL Department of anesthes 9440483910 COLLEGE iology,superspeciality block,sanathnagar [email protected] Hyderabad m TELANGANA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTITUTIONAL Approved 29/08/2019 No ETHICS COMMITTEE Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Other specified disorders of the skin and subcutaneous tissue related to radiation Patients Phimosis Patients Unilateral inguinal hernia, without obstruction or gangrene Intervention / Type Name Details Comparator Agent Intervention Melatonin syrup 0.2mg/kg,orally,single dose Comparator Agent Midazolam 0.5mg/kg,orally,single dose Inclusion Criteria Inclusion Criteria Age From 2.00 Year(s) Age To 10.00 Year(s) Gender Both

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Details ASA 1 AND 2 SHEDULED FOR ELECTIVE SURGERY
INFORMED WRITTEN CONSENT Exclusion Criteria Exclusion Criteria Details 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 Method of Generating Computer generated randomization Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Sedation and anxiety scores after premedication. Just before premedication. Induction dose of propofol 90 minutes after premedication. Before induction. 10minutes after extubation.

Secondary Outcome Outcome Timepoints INDUCTION DOSE OF PROPOFOL After loss of eyelash reflex Target Sample Size Total Sample Size=70 Sample Size from India=70 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 13/06/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details nill 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

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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.

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