| CTRI Number |
CTRI/2015/03/005606 [Registered on: 04/03/2015] Trial Registered Retrospectively |
| Last Modified On: |
03/01/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of desflurane and propofol on recovery profile of children after short (60 minutes or less) surgeries requiring short postoperative stay |
|
Scientific Title of Study
|
Recovery profile after general anaesthesia in paediatric ambulatory surgeries : Desflurane versus Propofol |
| Trial Acronym |
DesvsProp |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Jain |
| Designation |
Junior resident |
| Affiliation |
Government Hospital and College, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care
GMCH,Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
aditi.jain.the1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satinder Gombar |
| Designation |
Professor and Head |
| Affiliation |
Government Hospital and College, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care
GMCH,Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
dr_sgombar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Jain |
| Designation |
Junior resident |
| Affiliation |
Government Hospital and College, Chandigarh |
| Address |
Department of Anaesthesia and Intensive care
GMCH,Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
aditi.jain.the1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical college
Sector32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
GMCH |
| Address |
GMCH-32 chandigarh |
| Type of Sponsor |
Government 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 |
| Aditi Jain |
Department of Anaesthesia and Intensive care, Govt Medical College |
Sector 32
Chandigarh
CHANDIGARH |
9876065424
aditi.jain.the1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients for ambulatory surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desflurane |
Desflurane inhalational for maintenance of general anaesthesia titrated to entropy values 40-60 |
| Comparator Agent |
Propofol |
Propofol infusion for maintenance of general anaesthesia titrated to entropy values of 40-60 |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and II scheduled for short duration elective surgeries with controlled ventilation |
|
| ExclusionCriteria |
| Details |
1.Acute symptoms of URTI in previous 2 weeks
2.Congenital heart disease
3.Chronic Pulmonary disease
4.Behavioral disorder
5.Allergy to anaesthetic agents |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of awakening |
Time of awakening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic variability |
during general anaesthesia |
| cost comparison |
during general anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Children form a sub-population that requires special care and enhanced vigilance during the perioperative period. Short paediatric surgeries and ambulatory procedures further require anaesthesia that offers quick recovery without compromising the safety of the patient. Studies comparing various agents for ambulatory surgeries have primarily focused on adult populations. Also, none of the studies conducted have used entropy as guidance in paediatric population.The post operative events may undergo a change if there is over or under use of agent for maintenance in the absence of anaesthesia of equal and sufficient depth. The present study will evaluate entropy guided comparison of two preferred agents - propofol and desflurane - for patient awakening time from general anesthesia in paediatric ambulatory surgeries.The cardiovascular and recovery profile along with the costs required for anaesthesia maintenance in the two groups will also be compared. |