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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  
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 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  
Status 
Not Applicable 
 
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.


 
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