| 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
|
|
|
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
|
|
|
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
|
|
|
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. |