| 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
|
|
|
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
|
|
|
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) |