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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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