CTRI Number |
CTRI/2020/06/026057 [Registered on: 23/06/2020] Trial Registered Prospectively |
Last Modified On: |
29/06/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of General anesthesia and Total intravenous anesthesia |
Scientific Title of Study
|
Comparision of General anesthesia with Isoflurane and Total intravenous anesthesia with Propofol and Fentanyl for paediatric patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Madhusudhanan T |
Designation |
M.D |
Affiliation |
vinayaka missions medical college and hospital |
Address |
20, Pg quarters,
vinayaka missisons medical college and hospital,
karaikal. Karaikal PONDICHERRY 609609 India |
Phone |
|
Fax |
|
Email |
ttmmaaddhhuu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Cheran K |
Designation |
D.N.B |
Affiliation |
vinayaka missions medical college and hospital |
Address |
department of anesthesia
vinayaka missisons medical college and hospital,
karaikal. Karaikal PONDICHERRY 609609 India |
Phone |
|
Fax |
|
Email |
pallavi1220@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Madhusudhanan T |
Designation |
M.D |
Affiliation |
vinayaka missions medical college and hospital |
Address |
20, Pg quarters,
vinayaka missisons medical college and hospital,
karaikal. Karaikal PONDICHERRY 609609 India |
Phone |
|
Fax |
|
Email |
ttmmaaddhhuu@gmail.com |
|
Source of Monetary or Material Support
|
vinayaka misisons research foundation |
|
Primary Sponsor
|
Name |
vinayaka missions medical college and hospital |
Address |
Keezhakasakudy Medu, Kottucherry Post,
karaikal -609609 |
Type of Sponsor |
Private medical college |
|
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 |
Madhusudhanan |
vinayaka missions medical college and hospital |
Keezhakasakudy Medu, Kottucherry Post, Karaikal PONDICHERRY |
9442145686
ttmmaaddhhuu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
vinayaka missions medical college |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
inhalational agent sevoflurane |
2- MAC
Route - inhalational
and titrated accordingly with hemodynamic changes
inhalational agent is turned off at the end of surgery
|
Intervention |
Propofol and Fentanyl |
PROPOFOL
induction dose - 2mg/kg IV
infusion dose - 50-150mcg/kg/min
Intravenous route
FENTANYL
induction dose - 4-20mcg/kg IV
infusion dose -2-10mcg/kg/hr
Both the drugs are titrated based on the hemodynamic variability and stopped at the end of surgery |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
asa1 & 2 |
|
ExclusionCriteria |
Details |
patient refusal
ASA 3 & 4
hypersensitivity to study drugs |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Hemodynamic changes - Heart rate, Mean arterial pressure, Sp02, ETCo2. |
In Intraoperative period - before induction, after induction, 5min, 10mins, 15 mins, 30 mins till end of procedure and Postoperative period |
|
Secondary Outcome
|
Outcome |
TimePoints |
Adverse events associated with General anesthesia with Isoflurane and Total intravenous anesthesia with Propofol and Fentanyl |
In Postoperative period at 1hour, 2hours till 12hours |
|
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)
|
28/06/2020 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Long term effects of Inhalational agents on development is not known Emergence delirium is common in the recovery period
so Total intravenous anaesthesia is being studied for replacing it in paediatric patients |