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CTRI Number  CTRI/2025/08/093722 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 25/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of propofol and a combination of propofol-ketamine as sedation drugs for their effect on lung function in children undergoing magnetic resonance imaging procedures 
Scientific Title of Study   Impact of Propofol vs Propofol-ketamine sedative regimen on lung atelectasis and diaphragm function in children undergoing magnetic resonance imaging: A Randomized Clinical Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shibani Padhy 
Designation  Additional Professor 
Affiliation  Nizams Institute of medical sciences 
Address  Room No-2, Faculty Anaesthesia room, Main OT complex, Department of Anaesthesiology, Old block, Nizams Institute of medical sciences, Punjagutta, Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  8332921975  
Fax    
Email  drshibanipadhy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shibani Padhy 
Designation  Additional Professor 
Affiliation  Nizams Institute of medical sciences 
Address  Room number 2, Faculty Anaesthesia room Main OT complex, Old block, Nizams Institute of medical sciences, Punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  8332921975  
Fax    
Email  drshibanipadhy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shibani Padhy 
Designation  Additional Professor 
Affiliation  Nizams Institute of medical sciences 
Address  Room number 2, Faculty Anaesthesia room Main OT complex, Old block, Nizams Institute of medical sciences, Punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  8332921975  
Fax    
Email  drshibanipadhy@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shibani Padhy 
Address  Anaesthesia faculty room number 2, Main OT complex, Old block, Nizams Institute of medical sciences, Punjagutta Hyderabad, Telangana Falt 307 , sreemukh kontham towers, Brahmanwadi, Begumpet 
Type of Sponsor  Other [self] 
 
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 
Shibani Padhy  Nizams Institute of medical sciences  Anaesthesia faculty room number 2, Main OT complex, Old block, Nizams Institute of medical sciences, Punjagutta Hyderabad, Telangana Falt 307 , sreemukh kontham towers, Brahmanwadi, Begumpet
Hyderabad
TELANGANA 
8332921975

drshibanipadhy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committee , Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Propofol Group  Participants will receive 0.2mL/kg of 1% propofol and 2 mL of 0.9% saline (total mixture-2ml), followed by a continuous infusion of propofol at a rate of 200 µg/kg/min and 0.9% saline at a rate of 0.04 mL/kg/min. 
Intervention  Propofol-Ketamine Group  Participants will receive 0.2 mL/kg of 0.5% propofol (mixture of 1% propofol and 0.9% saline) and 1 mg/kg of diluted ketamine in 0.9% saline (total 2 mL), followed by a continuous infusion of propofol at rate of 100µg/kg/min and ketamine at a rate of 20µg/kg/min. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  ASA physical status I to II
Elective MRI
Under Deep Sedation 
 
ExclusionCriteria 
Details  1. History of thoracic surgery
2. Associated pulmonary pathology eg. atelectasis,
pneumonia, pneumothorax, or pleural effusion
based on preoperative chest roentgenogram or
Ultrasound and CT chest when available 3.Current respiratory infection with fever greter than 38°C, purulent cough, yellowish nose discharge, or wheezing sound,
4. Airway abnormality
5. Allergy or contraindications for the study drugs
6. Duration of MRI more than 2hours
7. Patient refusal
8. Inability to obtain a pre sedation baseline USG scan  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The incidence of pulmonary atelectasis determined by lung ultrasonography. Atelectasis is defined as a juxtapleural consolidation score (C score) greater than 1 in more than one region, as determined by the lung ultrasound examination  From starting of anaesthesia to lung Ultrasound in the postsedation period. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total lung score
2. Diaphragm excursion
3. Outcome:Respiratory complications
4. Outcome:Image quality
5. Adverse events during sedation and recovery
6. Recovery Profile(time to emergence and duration of PACU stay) 
72hrs post MRI 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   Phase 4 
Date of First Enrollment (India)   05/09/2025 
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="1"
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 due consent the patients are shifted into MRI suite, ASA standard monitors will be applied. Baseline Lung and  diaphragm sonography will be performed by an experienced investigator who are blinded to the group allocation, using ultrasound system  and baseline C score, totql lung score and diaphragm excursion noted.

The primary MRI anesthesia senior resident will open the sealed envelope and prepare the study drug as per the group allocation, who otherwise will have any involvement in this study. and the patients will receive either of the following sedative regimes:

Group A patients that is  Propofol group participants will receive  propofol and saline  followed by a continuous infusion of propofol 

Group B patients that is Propofol ketamine group Participants will receive  propofol and ketamine followed by a continuous infusion of propofol .

The above MRI sedation protocol will be carried out by Anaesthesia consultant posted in MRI as per the group allocation and will not be a further part of the study. The ultrasonography will be performed by one of the investigators blinded to the study group in question. The video clip and images of the performed USG scan will be stored for review.

After MRI scan, all patients will be shifted to PACU and a repeat USG lungs and diaphragm will be performed and data on C score, Total lung score and Diaphragm excursion noted. Patients will be kept for monitoring in PACU for a minimum of 6 hours and then followed up from the day of MRI to 72 hours after MRI sedation by telephonic interview of parents at 24 hours,48 hours and 72 hours from the MRI scan. A pre established structured questionnaire designed to screen patients for any features of postoperative pulmonary complications will be used for the purpose. The parents would have been informed about the proposed telephonic interview and the questionnaire on the day of the Pre-anaesthetic assessment.

All participating patients, regardless of the study arm to which they are randomized, will be monitored and managed according to the general standard of care practices.  
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