FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/058560 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of single dose dexamethasone on variation in Blood Glucose level in pediatric hypospadias surgery: A Prospective Randomised controlled study in department of Anesthesia, SMS Medical college, Jaipur 
Scientific Title of Study   A Randomized,controlled,Study for effect of single dose of intraoperative dexamethasone on variation in blood glucose level in pediatric hypospadias surgery in department of anesthesia,SMS Medical College,Jaipur 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelam Dogra 
Designation  Senior Professor 
Affiliation  SMS MEDICAL COLLEGE,JAIPUR 
Address  Department of Anesthesia, J K Lon Hospital, OT-2nd Floor affiliated to SMS Medical College, JLN Marg, Jaipur. Rajasthan 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  Neelam_dogra24@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neelam Dogra 
Designation  Senior Professor 
Affiliation  SMS MEDICAL COLLEGE,JAIPUR 
Address  Department of Anesthesia, J K Lon Hospital, Ot-2nd Floor SMS Medical College, Jaipur. Rajasthan 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  Neelam_dogra24@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Isha Malhotra 
Designation  Junior Resiadent 
Affiliation  SMS MEDICAL COLLEGE,JAIPUR 
Address  Department of Anesthesia,SMS Medical College, Jaipur, Jaipur RAJASTHAN 302004 INDIA

Jaipur
RAJASTHAN
302004
India 
Phone  8360447884  
Fax    
Email  kandrix2796@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology SMS Medical College and Attached Hospitals 
 
Primary Sponsor  
Name  Sawai Man Singh Medical College 
Address  Department of Anesthesia, Ist floor, JK LONE Hospital,assocoated with SMS Medical College,Jaipur 
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 
Dr Neelam Dogra  J.K. LON HOSPITAL, Affiliated to SMS Medical College, Jaipur  Department of Anesthesia, 2nd floor OT, J.K. LON HOSPITAL,JLN Marg Adarsh Nagar Jaipur Pin 302004 Jaipur RAJASTHAN
Jaipur
RAJASTHAN 
9928709289

Neelam_dogra24@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Ethics Committee,SMS Medical College and attached hospitals.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q549||Hypospadias, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  normal saline  Patients will be administered normal saline flush in a 5 ml syringe and blood glucose will be monitored 2 hours post the administration and for 3 post-operative days to note the difference from baseline blood glucose levels. In the post operative period, PONV score, FLACC score, doses of rescue analgesia required, Fever and surgical site infection will be assessed at various time intervals 
Intervention  single dose of intraoperative dexamethasone  Patients will be administered a single dose of I.V. dexamethasone (0.15mg/kg) intraoperatively and blood glucose will be monitored 2 hours post the administration and for 3 post-operative days to note the difference in blood glucose levels from that of baseline. In the post-operative period,PONV score, Flacc score, doses of rescue analgesia required ,fever and Surgical site infection will be assessed at various time intervals. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Male 
Details  Children (3-6 years) undergoing hypospadias surgery.
Parents/caretaker willing to consent for participation.
Patients belonging to American society of Anesthesiologists (ASA) grade I and II 
 
ExclusionCriteria 
Details  Patients with Diabetes Mellitus.
Patients on immunosuppressive /steroid therapy.
Patients with known allergy to dexamethasone.
Patients with hepatorenal dysfunction. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate & compare the difference, in change in blood glucose levels at various time points in dexamethasone v/s control group.  Baseline(pre_operative),
2 hours after administration of dexamethasone/saline,
Fasting blood sugar and Post prandial blood sugar on :
Post_operative day: 1,2 and 3. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess & compare the difference in mean no of doses & total doses of rescue analgesic needed in post-operative period upto 12 hours in both the groups.
2. To assess & compare the difference in proportion of patients who experienced post-operative nausea, vomiting upto 12 hours in both the groups.
3. To assess & compare the percentage of patients who experienced side effects
( fever, surgical site infection) in both the groups. 
1. To assess & compare the difference in mean no of doses & total dose of rescue analgesic needed in post-operative period upto 12 hours in both the groups.
2. To assess & compare the difference in proportion of patients who experienced post-operative nausea, vomiting, upto 12 hours in both the groups.
3. To assess & compare the percentage of patients who experienced side effects (fever, surgical site infection) in both the groups. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   20/10/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   After obtaining Institutional Ethics Committee approval and written informed consent, 72 patients fulfilling inclusion criteria and undergoing elective surgery for hypospadias will be included.

Patient satisfying inclusion criteria and Pre anesthetic check up(PAC) fitness will be selected and taken into OT. Patient will be identified and informed written consent will be checked. Randomization will be done using opaque sealed envelope method. All monitors will be attached and baseline vitals will be recorded. Baseline blood sugar will be recorded and Glycopyrrolate(5ug/kg) Midazolam (0.05mg/kg) and Fentanyl (2ug/kg) will be administered to the patient via already secured I.V. line. Induction of the patient will be done using I.V. propofol 2mg/kg and I.V. atracurium(0.5mg/kg) to facilitate endotracheal intubation to secure airway  in every patient. Now, Group A will be administered single dose of dexamethasone(0.15mg/kg) and Group B  will be given saline through prefilled 5ml syringes that the anesthesiologist administering will not know about because of the blinding process. Post that, the patient will be put to left  lateral position and under all aspetic preacautions ,painting and draping will be done at and around the caudal block site, and caudal block will be administered to the patient using ropivacaine (0.2%) in dose 0.5 ml/kg. Blood glucose will be recorded 2 hours after administering dexamethasone. Maintainence of anesthesia will be done by oxygen, nitrous oxide and sevoflurane.  At the end of surgery, all the anesthetic agents will be discontinued and patient will be taken on 100% oxygen. Reversal of neuromuscular block will be done by I.V. neostigmine(0.05 mg/kg) and I.V. Glycopyrrolate (0.01mg/kg). On regain of adequate muscle power ,extubation will be done and the patient will be shifted to recovery room.
Post surgery ,patient will be assessed at regular time points for post-operative pain (using FLACC score), nausea,vomiting,fever,surgical site infection. Fasting blood sugar and post-prandial blood sugar will be recorded upto 72 hours of post-operative period. 
 
Close