| CTRI Number |
CTRI/2021/02/030983 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
02/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post operative agitation and hyperactivity in children can be reduced by
dexmedetomidine and propofol-which is better |
|
Scientific Title of Study
|
Comparison of incidence of emergence delirium in paediatric patients undergoing general anaesthesia using Propofol and Dexmedetomidine: A randomized comparative open label trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidya Tharu K |
| Designation |
PG resident |
| Affiliation |
Dr S N Medical College Jodhpur |
| Address |
Department of anesthesiology and critical care
Dr S N Medical College
Jodhpur
RAJASTHAN 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9945967946 |
| Fax |
|
| Email |
vidyatharu93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Janweja |
| Designation |
Senior Professor |
| Affiliation |
Dr S N Medical College Jodhpur |
| Address |
Department of anesthesiology and critical care
Dr S N Medical College
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
sarita.janweja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Janweja |
| Designation |
Senior Professor |
| Affiliation |
Dr S N Medical College Jodhpur |
| Address |
Department of anesthesiology and critical care
Dr S N Medical College
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9829116420 |
| Fax |
|
| Email |
sarita.janweja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S N Medical College Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr S N Medical College Jodhpur |
| Address |
Dr S N Medical College
Shastri Nagar
Residency Road
Jodhpur
Rajasthan
342001 |
| 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 |
| Vidya Tharu K |
Umaid hospital |
Operation theatre complex
First floor
Umaid Hospital
Department of anaesthesiology and critical care
Dr S N Medical College
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9945967946
vidyatharu93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Dr Sampurnanand medical college , Jodhpur |
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 |
General Anaesthesia under inhalational agent sevoflurane |
Comparative Drugs Propofol or Dexmedetomidine will be given before extubation and their effect on emergence delirium will be assessed in post operative period. In group P Propofol 0.5mg.kg-1 and in group D Dexmedetomidine 0.3µg.kg-1 will be given as bolus intravenously 15 minutes prior to commencement of extubation. Inhalational agent sevoflurane which was opened according to MAC will be stopped when the surgeon starts the skin
suturing. |
| Comparator Agent |
Propofol, Dexmedetomidine |
Group P will receive Propofol and Group D will receive Dexmedetomidine and the effect on emergence agitation in post
operative period will be assessed. In group P Propofol
0.5mg.kg-1 and in group D Dexmedetomidine 0.3µg.kg-1 will be given as bolus intravenously 15 minutes prior to commencement of extubation. Inhalational agent sevoflurane which was opened according to MAC will be stopped when the surgeon starts the skin
suturing.
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 2 to 6 years of either gender of ASA PS I and II undergoing surgery under general anaesthesia with sevoflurane lasting less than 120min |
|
| ExclusionCriteria |
| Details |
1.Parents’ refusal.
2.Patients posted for elective surgery under regional anaesthesia.
3.ASA III and IV
4.Patients with active URI.
5.Patient with history of previous psychiatric illness.
6.Patients with a history of developmental delay
7.Patients having congenital airway problems, cardiac disorders or syndromic babies
8.Patients having psychological disorders, epilepsy and allergy to the study medications
9.Surgeries lasting for more than 120 min
10.Surgeries requiring endotracheal tube insertion for securing the airway
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of emergence delirium in subjects receiving propofol or dexmedetomidine at the end of surgery with sevoflurane anaesthesia during a period of six months. |
30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic parameters (HR, SBP, DBP, MAP, RR, SpO2, and ECG), sedation level, recovery time and post-operative pain between groups receiving propofol and dexmedetomidine. |
30 min |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/02/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
By assessment and
comparison of propofol and dexmedetomidine in paediatric patients undergoing
sevoflurane anaesthesia, we wish to see the difference in the incidence of
emergence delirium in these patients. |