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
|
|
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
|
|
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. |