| 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
|
|
|
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
|
|
|
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. |