CTRI Number |
CTRI/2023/11/059539 [Registered on: 06/11/2023] Trial Registered Prospectively |
Last Modified On: |
02/07/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
comparison of two sedation technique in children with congenital heart disease. |
Scientific Title of Study
|
Comparison of two different techniques of sedation in children with complex cardiac
disease undergoing CT angiography; Prospective Randomised Study |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
AJAY SINGH |
Designation |
Assistant Professor |
Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
Address |
Department of Anaesthesia & Intensive Care, 4th Floor, Nehru Hospital, Chandigarh 160012. Department of Anaesthesia & Intensive Care, 4th Floor, Nehru Hospital, Chandigarh 160012. Chandigarh CHANDIGARH 160011 India |
Phone |
09999276845 |
Fax |
|
Email |
ajay.ydv2509@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
AJAY SINGH |
Designation |
Assistant Professor |
Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
Address |
Department of Anaesthesia & Intensive Care, 4th Floor, Nehru Hospital, Chandigarh 160012. Department of Anaesthesia & Intensive Care, 4th Floor, Nehru Hospital, Chandigarh 160012. Chandigarh CHANDIGARH 160011 India |
Phone |
09999276845 |
Fax |
|
Email |
ajay.ydv2509@gmail.com |
|
Details of Contact Person Public Query
|
Name |
AJAY SINGH |
Designation |
Assistant Professor |
Affiliation |
Post Graduate Institute of Medical Education & Research, Chandigarh |
Address |
Department of Anaesthesia & Intensive Care, 4th Floor, Nehru Hospital, Chandigarh 160012. Department of Anaesthesia & Intensive Care, 4th Floor, Nehru Hospital, Chandigarh 160012. Chandigarh CHANDIGARH 160011 India |
Phone |
09999276845 |
Fax |
|
Email |
ajay.ydv2509@gmail.com |
|
Source of Monetary or Material Support
|
Post Graduate Institute of Medical Education & research, Sector 12,Chandigarh 160012, India |
|
Primary Sponsor
|
Name |
Post Graduate Institute of Medical Education ResearchChandigarh |
Address |
sector 12, Chandigarh 160012, India |
Type of Sponsor |
Research institution and hospital |
|
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 Ajay Singh |
Advanced Pediatric Centre, Post Graduate Institute of Medical Education & Research, Chandigarh |
CT Room, Ground Floor, Advanced Pediatric Centre, Post Graduate Institute of Medical Education & Research, Chandigarh 160012, India Chandigarh CHANDIGARH |
09999276845
ajay.ydv2509@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee, Post Graduate Institute of Medical Education & Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B||Imaging, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
CT Table with ketamine |
a combination of midazolam 0.05 mg/kg, glycopyrrolate
0.01 mg/kg and ketamine 0.5 mg/kg iv with the child on the CT table inside the CT suite. Ketamine
will be titrated every 30 seconds in steps of 0.25 mg/kg to achieve a Paediatric Sedation
State Scale (PSSS) of 2. Total duration uo to 6 hours. |
Intervention |
PARENTS LAP WITH KETAMINE |
a combination of midazolam 0.05 mg/kg, glycopyrrolate
0.01 mg/kg and ketamine 0.5 mg/kg iv with the child in the parents lap inside the CT suite. Ketamine
will be titrated every 30 seconds in steps of 0.25 mg/kg to achieve a Paediatric Sedation State Scale (PSSS) of 2. Total duration up to 6 hours. |
|
Inclusion Criteria
|
Age From |
6.00 Month(s) |
Age To |
3.00 Year(s) |
Gender |
Both |
Details |
child with diagnosed complex
cyanotic congenital heart disease (ASA III or IV) with baseline saturation less than 90 per cent
requiring sedation for cardiac CT angiography. |
|
ExclusionCriteria |
Details |
1. Acyanotic CHD
2. Older children >3 years
3. refusal of consent by parents
4. Active URI
5. Contraindication for contrast (CKD)
6. Contrast allergy
7. Full stomach children |
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To quantify the difference in dose of ketamine required to achieve a Pediatric Sedation State
Scale of 2 between the two techniques (lap vs table). |
From the onset of the sedation process till the achievement of PSSS 2. up to 30 minutes. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To record any episodes of desaturation and bradycardia (reversal of shunt).
2. To record the total amount of ketamine required during the whole procedure.
3. To compare the time to achieve the Paediatric Sedation State Scale of 2
4. Time required to awaken the child, the Watcha scale will be noted every 10 minutes in the recovery room till a Steward scale of 7 has been achieved. |
From 30 minutes before the sedation till discharge |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
15/11/2023 |
Date of Study Completion (India) |
10/07/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
10/07/2024 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
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
|
For the study, two groups of patients will be taken. After a thorough pre-anaesthetic evaluation, confirming fasting status and obtaining parental consent, baseline vitals (HR, Oxygen saturation) will be recorded. Patients will be randomly allocated to one of two groups using computer-generated random numbers. Preoperative anxiety will be scored at 2 time points – in the preoperative holding area and at the time of administration off sedative, using the modified Yale Preoperative Anxiety Scale (mYPAS)16. Following this Group A children will be given a combination of midazolam 0.05 mg/kg, glycopyrrolate 0.01 mg/kg and ketamine 0.5 mg/kg iv in the mother’s lap inside the CT suite. Ketamine will be titrated every 30 seconds in steps of 0.25 mg/kg to achieve a Paediatric Sedation State Scale (PSSS) of 2. Group B children will also be given the same combination but after shifting the child inside the CT suite on the CT table. A maximum cumulative dose of 2 mg/kg of ketamine will be used during induction of sedation. If the child fails to achieve an PSSS of 2 at this maximum dose, the child will be excluded from the study and alternative sedatives will be used at the treating clinician’s discretion. The total requirement of ketamine required for keeping the child sedated (PSSS of 2) child during the whole procedure will be recorded. If the child moves during the procedure or is agitated, it will be noted and an additional bolus of 0.25 mg/kg of ketamine will be given to achieve an PSSS of 2 in both the groups. The amount of bolus/number of boluses required will be recorded. Any episodes of desaturation (10% from baseline), cyanosis and apnea will be noted. After the procedure, the child will be shifted to the recovery room with oxygen and the time required to awaken the child will be noted. |