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CTRI Number  CTRI/2025/09/095312 [Registered on: 23/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A study to observe the occurrence of respiratory side effects of propofol anesthesia in children undergoing adenoid and tonsil surgeries. 
Scientific Title of Study   Incidence of peri-operative respiratory adverse events with target-controlled infusion of propofol anesthesia in pediatric adenoidectomy and tonsillectomy surgeries - An observational 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  SINDHUJA T 
Designation  Associate consultant 
Affiliation  SAKRA WORLD HOSPITAL 
Address  Department of Anesthesia, Sakra World Hospital, SY NO 52/2 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI, BANGALORE, KARNATAKA 560103
SY NO 52/2 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI, BANGALORE, KARNATAKA 560103
Bangalore
KARNATAKA
560035
India 
Phone  9833632923  
Fax    
Email  sindtdr@gamil.com  
 
Details of Contact Person
Scientific Query
 
Name  SINDHUJA T 
Designation  Associate consultant 
Affiliation  SAKRA WORLD HOSPITAL 
Address  Department of Anesthesia, Sakra World Hospital, SY NO 52/2 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI, BANGALORE, KARNATAKA 560103
SY NO 52/2 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI, BANGALORE, KARNATAKA 560103

KARNATAKA
560035
India 
Phone  9833632923  
Fax    
Email  sindtdr@gamil.com  
 
Details of Contact Person
Public Query
 
Name  SINDHUJA T 
Designation  Associate consultant 
Affiliation  SAKRA WORLD HOSPITAL 
Address  Department of Anesthesia, Sakra World Hospital, SY NO 52/2 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI, BANGALORE, KARNATAKA 560103
SY NO 52/2 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI, BANGALORE, KARNATAKA 560103

KARNATAKA
560035
India 
Phone  9833632923  
Fax    
Email  sindtdr@gamil.com  
 
Source of Monetary or Material Support  
Sakra World Hospital, SY NO 52/2 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI, BANGALORE, KARNATAKA 560103 
 
Primary Sponsor  
Name  Not applicable 
Address  NOT APPLICABLE 
Type of Sponsor  Private hospital/clinic 
 
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 
SINDHUJA T  SAKRA WORLD HOSPITAL  operation theatre, 2nd floor, Department of Anesthesia, SY NO 52/2, 52/3, DEVARABEESANAHALLI, OUTER RING ROAD, MARATHAHALLI
Bangalore
KARNATAKA 
9833632923

sindtdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAKRA WORLD HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  All children undergoing elective Adenoidectomy or Tonsillectomy or Adeno tonsillectomy surgeries from 4 to 16 years of age belonging to American Society of Anaesthesiologist Physical Status (ASA PS) 1 and 2 
 
ExclusionCriteria 
Details  1)lack of parental consent for the child’s participation
2)children with hypersensitivity to the drugs used in study
3)children with congenital anomalies, mitochondrial myopathy, cerebral palsy, musculo-skeletal disorders or any moderate to severe systemic illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To record the occurrence of perioperative respiratory adverse events which include laryngospasm, bronchospasm, breath holding, coughing, desaturation  1. at induction of Anesthesia
2. at maintenance of Anesthesia
3. at extubation
4. in post anesthesia care unit (for 1 hour) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To record the concentration of propofol at effect site (Ce) using Eleveld TCI pharmacokinetic model of propofol for
.maintenance of anaesthesia under BIS guidance
.Wake up concentration
2.Time to wake up after termination of infusion
3.Total propofol consumption (in mg/kg/hr)
4.Post extubation sedation score
5.Emergence delirium
 
AT THE END OF SURGERY 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   N/A 
Date of First Enrollment (India)   15/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 institutional ethical committee clearance, patients will be selected for the study based on inclusion and exclusion criteria,  and informed written consent/ assent will be obtained from the parents/ child during the pre-anaesthesia check-up.

Patients will be assessed before the procedure in pre-anaesthetic check-up (PAC) visit and  thorough history taking and examination will be done. Standard pre-operative nil per oral advise will be given.

In the OT, a standard inhalational induction of anaesthesia, (50% oxygen + 50% nitrous oxide and 2-8 % sevoflurane in increments) will be performed. ASA standard monitors (Electrocardiography, Pulse oximetry, Non-invasive blood pressure) and processed EEG monitor (to assess depth of anaesthesia) will be connected and baseline values recorded. IV cannula will be secured under inhalational anaesthesia. Nitrous oxide and sevoflurane will be turned off once iv cannula is secured. Inj Fentanyl 2 mcg/kg given and TIVA-TCI Eleveld model of propofol will be started at effect site concentration (Ce) 1 mcg/mL and titrated at increments of 0.5 mcg/mL to target BIS value between 40-60.

 inj atracurium 0.5 mg/kg IV will be given and after 4 min endotracheal intubation will be performed with appropriate sized endotracheal tube. Inj.Morphine IV at dose of 0.05 mg /kg bolus will be administered before incision and boluses of 0.025 mg/kg will be repeated if required to a maximum dose of 0.1 mg/kg. All patients will receive Inj.Dexamethasone 0.2 mg/kg, Inj.Paracetamol 15 mg/kg, Ibugesic 5 mg/kg for analgesia.

ECG, HR, MAP, Saturation (SpO2), end tidal co2 will be monitored continuously throughout the surgery and anaesthesia as per the standard intraoperative monitoring.

At the end of surgery, Inj.Ondansetron 0.1mg/kg will be given for postoperative nausea and vomiting prophylaxis. Then TIVA –TCI will be discontinued (i.e effect site concentration (Ce) set to 0 mcg/ml) and patient will be extubated once extubation criteria is met.

 

Values noted:

 

·      Ce value at maintenance of anaesthesia (mcg/ml)

·      Ce at return of responsiveness (RoR) (RoR is defined as awakening to verbal command or slight tapping).

·      the time taken for RoR after discontinuing propofol TCI.

·      the total propofol consumption (mg/kg/hr)

·      the total opioid consumption.

 

The patient will be shifted to post anaesthesia care unit and monitored for 60 minutes. The occurrence of following events will be documented:

 

·      Respiratory adverse events (laryngospasm, bronchospasm, cough, breath holding, airway obstruction, desaturation < 92%)

·      Sedation score (PASS – Paediatric Analog Sedation Score),

·      Emergence delirium score (PAED scale)

·      Postoperative nausea and vomiting (PONV)

·      Pain score (FACES scale for 4-7 years old and NRS scale for 7-16 years)          

 

 
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