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CTRI Number  CTRI/2023/06/053761 [Registered on: 12/06/2023] Trial Registered Prospectively
Last Modified On: 10/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Time taken to emerge from anaesthesia after dexmedetomidine or ketamine when used with propofol for anaesthesia in children undergoing urethral surgery 
Scientific Title of Study   Randomised controlled study to compare time to postoperative recovery after opioid free total intravenous anaesthesia using propofol either with ketamine or dexmedetomidine in children undergoing urethroplasty 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shweta Saini 
Designation  Post graduate First year resident 
Affiliation  Lady Hardinge Mecical College and associated Hospitals  
Address  Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India Department of Anaesthesia Lady Hardinge Medical College
Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India Department of Anaesthesia Lady Hardinge Medical College
Central
DELHI
110001
India 
Phone  8130799898  
Fax    
Email  sainishweta0797@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maitree Pandey 
Designation  Director Professor and Head of department of anaesthesia  
Affiliation  Lady Hardinge Mecical College and associated Hospitals  
Address  Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India Department of Anaesthesia Lady Hardinge Medical College
Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India Department of Anaesthesia Lady Hardinge Medical College
Central
DELHI
110001
India 
Phone    
Fax    
Email  maitreepandey@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Saini 
Designation  Post graduate First year resident 
Affiliation  Lady Hardinge Mecical College and associated Hospitals  
Address  Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India Department of Anaesthesia Lady Hardinge Medical College
Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India Department of Anaesthesia Lady Hardinge Medical College
Central
DELHI
110001
India 
Phone  8130799898  
Fax    
Email  sainishweta0797@gmail.com  
 
Source of Monetary or Material Support  
Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 Department of Anaesthesiology ,Lady Hardinge Medical college and associated hospitals  
 
Primary Sponsor  
Name  Lady Hardinge Medical College and Associated Hospitals 
Address  Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 , India 
Type of Sponsor  Government medical college 
 
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 Shweta Saini  Kalawati Saran children’s hospital   Connaught Circus, Bangla Sahib Rd, DIZ Area, Connaught Place, New Delhi, Delhi 110001 Kalawati Saran children’s hospital paediatric OT Department of Anaesthesia Lady Hardinge medical college and associated hospitals
Central
DELHI 
8130799898

sainishweta0797@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for human research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N36||Other disorders of urethra,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine with propofol  Dexmedetomidine @ 1µg/kg over ten minutes (body weight of the patient over 10min). This will be followed by flash induction of anaesthesia with propofol set at a target Cp of 3-6µg/ml to achieve BIS between 40-60 during intraoperative period 
Intervention  Ketamine with propofol  Ketamine@ 1mg/kg over 10 minutes (body weight of the patient over 10min). This will be followed by flash induction of anaesthesia with propofol set at a target Cp of 3-6µg/ml to achieve BIS between 40-60 during intraoperative period 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  11.00 Year(s)
Gender  Male 
Details  1. Male patients in the age group of 3-11yrs
2. ASA I and ASA II
3. Undergoing urethroplasty of duration 1-4 hours 
 
ExclusionCriteria 
Details  1.Any known allergy to drugs used in the study
2.Patients with language barrier/ mental retardation/ unable to communicate
3.Indication for use of opioids during surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of time taken (in minutes) to achieve modified Aldrete score of ≥ 9 [Mean ± SD or median (IQR)] using propofol either with ketamine or dexmedetomidine in children undergoing urethroplasty.  Immediate postoperative period  
 
Secondary Outcome  
Outcome  TimePoints 
Comparison between the groups
1.Mean plasma concentration of propofol (µg/ml)
2.Mean propofol requirement (µg/kg /min)
3. Mean difference between awake time predicted by the TCI pump & actual awake time
4. Mean total 24 hours post-operative analgesic requirement
5. Proportion of patients with occurrence of post-operative nausea & vomiting, irrelevant talk, hallucination, occurrence of explicit recall and haemodynamic complications (bradycardia, tachycardia, hypotension and hypertension) 
1.Immediate postoperative period
2.Immediate postoperative period
3. Immediate postoperative period
4. 24 hours
5. 24 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   21/06/2023 
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="1"
Months="4"
Days="29" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Results to be published in scientific journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Study will be conducted after approval by the Institutional Ethics Committee and will be registered with Clinical Trials Registry of India. Patients fulfilling the inclusion criteria will be recruited for the study. A careful pre-anaesthetic check-up including detailed history, physical examination, baseline investigations as per clinical requirements will be performed. A verbal assent from the subject and written informed voluntary parental consent will be obtained for anaesthesia, surgery and participation in the study. Randomisation and concealment of allocation will be done. This will be a double blind study in which the drugs as mentioned in the randomised envelopes will be prepared by a resident not involved in the study in identical syringes and volumes. The drug syringes will be labelled as per the code alloted to the patient. Ketamine and dexmedetomidine will be prepared in 20 ml syringes with a dilution of 2mg/ ml and 2mcg/ ml respectively. The observations of the study shall be made by an independent person not aware of the study groups.

Patients in Group I will receive ketamine@ 1mg/kg over 10 minutes (body weight of the patient over 10min).

Patients in group II will receive dexmedetomidine @ 1µg/kg  over ten minutes (body weight of the patient over 10min).

  This will be followed by flash induction of anaesthesia with propofol set at a target Cp of 3-6µg/ml to achieve BIS between 40-60. Airway shall be secured with weight appropriate 2nd generation supraglottic device (SGD). The correct placement shall be confirmed with capnography and lungs will be mechanically ventilated with O2+Air (FiO2 - 0.4) to maintain an EtCO2 of 30–35 mm Hg.

Under all aseptic precautions, caudal block will be administered using 0.75ml/kg of ropivacaine 0.2% with morphine (30µg/kg).

Anaesthesia will be maintained by infusion of propofol with a Fresenius Kabi target controlled infusion pump (Agilia SP TIVA), using the Paedfusor plasma model. Cp will be increased or decreased by 0.5µg/ml to maintain a BIS of 40-60. Analgesia will be maintained by either ketamine (Group I) @ 0.5mg/kg/hr (Body weight of the patient/ 4 ml/hr) or dexmedetomidine (group II) @ 0.5µg/kg /hr (Body weight of the patient/ 4 ml/hr) with an increment of 0.2mg/kg or 0.2µg/kg upto 1mg/kg or 1µg/kg respectively, if needed.

BIS will be recorded every 5 minutes. A record shall be maintained of the plasma concentration of propofol whenever it is changed and the number of changes made.

Haemodynamic parameters will be observed intraoperatively and side effects such as hypotension (BP < 20% baseline), bradycardia (fall in HR <20% from baseline or less than 50/ min),  hypertension (BP > 20% baseline) and tachycardia (HR >20% baseline) will be recorded and treated. Hypotension will be treated with either decreasing propofol if BIS is <40 or bolus of ringer lactate as required. Bradycardia will be treated by decreasing propofol rate if BIS <40, removing the surgical stimulus, or intravenous atropine 0.02mg/kg if HR< 60/min. Tachycardia and hypertension will be treated by increasing propofol Cp if BIS > 60 and then analgesic as required. Surgical causes and full bladder will be ruled out. In spite of these measures if tachycardia and/ or hypertension persists, it would be assumed due to pain and fentanyl 0.5µg/kg will be administered. If an opioid is administered intraoperatively, or the allocation code is broken at any point in the study, the case would be excluded from the analysis.

Ketamine or dexmedetomidine infusion will be stopped and intravenous paracetamol 15mg/kg over 15 min will be administered with the starting of skin sutures. With the last skin suture, Cp shall be noted and set to 1.5µg/ml. Time to awaken shall be noted from the pump, and infusion will be stopped. BIS shall be recorded at this point. This shall be denoted as T0. SGD will be removed when patient starts breathing spontaneously and regularly with adequate tidal volume. Time will be noted from T0 to removal of SGD (Te).  Time to spontaneous eye opening from T0 shall be considered as actual awake time. Modified Aldrete score will be observed every minute post removal of SGD and time taken to achieve modified Aldrete score  â‰¥ 9 (Annexure VI) from T0 will be noted (Tr) . Primary outcome i.e, the time to post-operative recovery (modified Aldrete score ≥ 9) will be taken from T0 to Tr. Presence of irrelevant talk and hallucination will be noted. Mean/median plasma concentration of propofol shall be calculated by �’plasma concentration/ n. Total propofol consumed will be noted at the end of procedure.

Multimodal analgesia will be provided with the help of paracetamol 15mg/kg 8 hourly. Pain assessment will done every 1/2 hourly for initial 2 hour then hourly for next 4 hours and then 6 hourly upto 24 hours using modified objective pain assessment score [MOPS (Annexure V)]. If the MOPS is ≥ 4 , or child demands analgesia, diclofenac 0.3mg/kg (max 50 mg)  will be administered intravenously. Total requirement of post-operative analgesia will be recorded. Patients will be asked if they remember any events during the procedure after recovery. A note shall also be made of the episodes of nausea and vomiting in 24 hours. Patients will be administered ondansetron 0.08 mg/ kg iv on demand for nausea and/ or vomiting keeping an interval of 8 hours between two doses. Total 24 hrs analgesic requirement will also be noted. 

 
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