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 Study
|
A comparitive study on effects of oral melatonin versus oral midazolam as premedicant in children undergoing surgery under general anesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
R DEVI SAI PRIYANKA |
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 |
rdspriyanka@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr GSUNANDA |
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 |
sunanda_gooty@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr GSUNANDA |
Designation |
Assistant Professor |
Affiliation |
Esi medical college and hospital |
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 |
sunanda_gooty@yahoo.com |
|
Source of Monetary or Material Support
|
ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL,Sanathnagar,Hyderabad,Telangana,500018 |
|
Primary Sponsor
|
Name |
ESIC MEDICAL COLLEGE |
Address |
ESIC MEDICAL COLLEGE AND SUPERSPECIALITY HOSPITAL,SANATH NAGAR,HYDERABAD,TELANGANA |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
R DEVI SAI PRIYANKA |
ESIC MEDICAL COLLEGE |
Department of anesthesiology,superspeciality block,sanathnagar Hyderabad TELANGANA |
9440483910
rdspriyanka@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K409||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, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Melatonin syrup |
0.2mg/kg,orally,single dose |
Comparator Agent |
Midazolam |
0.5mg/kg,orally,single dose |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
10.00 Year(s) |
Gender |
Both |
Details |
ASA 1 AND 2 SHEDULED FOR ELECTIVE SURGERY
INFORMED WRITTEN CONSENT |
|
ExclusionCriteria |
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 Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Sedation and anxiety scores after premedication.
Induction dose of propofol |
Just before premedication.
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 Enrollment (India)
|
13/06/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nill |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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 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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