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CTRI Number  CTRI/2021/03/031859 [Registered on: 10/03/2021] Trial Registered Prospectively
Last Modified On: 22/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of incidence of post-operative vomiting after squint surgery in children 
Scientific Title of Study   Post-operative vomiting after paediatric strabismus surgery: a comparison of propofol versus sevoflurane anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Subramanian 
Designation  Consultant Anaesthesiologist 
Affiliation  Narayana Nethralaya 2 
Address  Room no 105, OT, 1st floor, Narayana Nethralaya 2 Narayana Health City, Bommasandra, Bangalore 560099

Bangalore
KARNATAKA
560099
India 
Phone  740661022  
Fax    
Email  drshalinisubramanian@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Subramanian 
Designation  Consultant Anaesthesiologist 
Affiliation  Narayana Nethralaya 2 
Address  Room no 105, OT, 1st floor, Narayana Nethralaya 2 Narayana Health City, Bommasandra, Bangalore 560099

Bangalore
KARNATAKA
560099
India 
Phone  740661022  
Fax    
Email  drshalinisubramanian@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalini Subramanian 
Designation  Consultant Anaesthesiologist 
Affiliation  Narayana Nethralaya 2 
Address  Room no 105, OT, 1st floor, Narayana Nethralaya 2 Narayana Health City, Bommasandra, Bangalore 560099

Bangalore
KARNATAKA
560099
India 
Phone  740661022  
Fax    
Email  drshalinisubramanian@gmail.com  
 
Source of Monetary or Material Support  
Narayana Nethralaya, NN-2, NH health city, Bommasandra, Bangalore 560099 
 
Primary Sponsor  
Name  Narayana Nethralaya  
Address  Narayana Nethralaya 2 Naryana Health City, Bommasandra, Bangalore 560099  
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 
Dr Shalini Subramanian  Narayana nethralaya  OT complex, First floor,Narayana Nethralaya NN-2, Naryana Health City, Bommasandra, Bangalore 560099
Bangalore
KARNATAKA 
7406610222

drshalinisubramanian@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Nethralaya 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  Propofol  Propofol is an intravenous anaesthetic drug that is used for induction and maintenance of anesthesia. There are dosage guidelines for use of propofol for TIVA (total intravenous anaesthesia) in children and these are folllowed here. 
Comparator Agent  Sevoflurane  Sevoflurane based balanced anaesthesia is safe and affective for use in children. It is a standard anaesthetic agent and technique in children undergoing surgery 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  70 consecutive ASA I-II children aged 1-12 years undergoing strabismus surgery under general anaesthesia will be recruited after obtaining written parental consent. 
 
ExclusionCriteria 
Details  Patients with a known allergy to propofol, those with a known difficult airway and those with a severe neurological disorder will be excluded from the study 
 
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 
1. The primary outcome is to compare the incidence of postoperative vomiting in children undergoing strabismus surgery under intravenous versus balanced anaesthesia  0-2 hour, 2-6 hour and 6-24 hour  
 
Secondary Outcome  
Outcome  TimePoints 
2. The secondary outcome is to compare the incidence of emergence agitation in the two groups  0-2 hour 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   12/03/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Post-operative nausea and vomiting (PONV) is a significant problem after strabismus surgery. In the absence of any prophylaxis, the incidence of post-opeartive vomiting is 40-60%. Several factors including duration of surgery, use of volatile anaesthetic agents and nitrous oxide for maintenance of anaesthesia, use of opioids for analgesia in the post-opeartive period as well as history of motion sickness or PONV in the child have all been reported to be risk factors. Children belowtwelve years need general anaesthesia for squint surgery to ensure immobility and pain relief. Among the anaesthetic agents, use of inhalational agents(isoflurane, sevoflurane, desflurane, nitrous oxide) have all been implicated in increasing the risk of PONV. In TIVA(totally intravenous anaesthesia) technique, oxygen and are the only gases used and anaesthesia is maintained using an infusion of propofol. This technique has been found to reduce e PONV in other types of surgery . The primary outcome is to compare the incidence of postoperative vomiting in children undergoing strabismus surgery under intravenous versus balanced anaesthesia. The secondary outcome is to compare the incidence of emergence agitation in the two groups. This study is unique in being the first to compare sevoflurane (without nitrous oxide)and propofol  as agents for maintenance of anaesthesia  in squint surgery in children aged 1-12 years. 70 children will be randomized into one of the two groups S or P w, in whom anaesthesia will be maintained using sevoflurane balanced anesthesia or TIVA with propofol respectively. They will be intubated after administration of injection fentanyl 2 µg/kg and atracurium 0.5mg/kg. Both groups will receive ondansetron 0.1mg/kg, dexamethasone 0.1mg/kg intravenously as anti-emetic prophylaxis and paracetamol 15mg/kg intravenously for post-operative analgesia. The intra-operative hemodynamics  like heart rate, blood pressure, total dose of Fentanyl and atracurium as well as the duration of surgery and anaesthesia will be noted. At the end of surgery, the child will be monitored in the post anaesthesia care unit. The emergence delirium will be noted using a PAED (paediatric anaesthesia emergence delirium) score. Any episode of postoperative nausea or vomiting in the 0-2 hour, 2-6 hour and 6-24 hour period will be recorded. Retching is also considered as vomiting. Rescue antiemetic ondansetron 0.1 mg/kg will be administered if there is more than one episode of vomiting. The end point of the study is reached at 24 hour.

 
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