| CTRI Number |
CTRI/2024/10/075390 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to compare the Effect of two doses of Dexmedetomidine on restlessness with Desflurane anesthesia in paediatric patient |
|
Scientific Title of Study
|
Comparing two doses of dexmedetomidine infusion on emergence agitation using desflurane in paediatric surgeries under general anesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashima Yadav |
| Designation |
Post Graduate Trainee |
| Affiliation |
Aiims BHOPAL |
| Address |
Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh
Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7002187751 |
| Fax |
|
| Email |
ashimayadav0703@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishali Waindeskar |
| Designation |
Professor & Head of department |
| Affiliation |
Aiims BHOPAL |
| Address |
Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh
Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Waindeskar |
| Designation |
Professor and Head of Department |
| Affiliation |
Aiims BHOPAL |
| Address |
Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh
Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Vaishali Waindeskar |
| Address |
department of anesthesia AIIMS saket nagar bhopal |
| Type of Sponsor |
Other [guide (hod)] |
|
|
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 Ashima Yadav |
All India Institute Of Medical science bhopal |
Department of Anesthesiology, 3rd floor Hospital building , All India Institute Of Medical Science. Bhopal , Saket Nagar , Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
7002187751
ashimayadav0703@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BHOPAL INSTITUTIONAL HUMAN ETHICS COMMITTEE STUDENT RESEARCH (IHEC-SR) |
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 |
| Comparator Agent |
intravenous dexmedetomidine |
intravenous dexmedetomidine intraoperative dexmedetomidine infusion @ 0.1mcg/kg/hr |
| Intervention |
intravenous dexmedetomidine |
intravenous dexmedetomidine intraoperative dexmedetomineinfusion at 0.2mcg/kg/hr |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Age 2-8 years either gender
ASA 1 & 2 |
|
| ExclusionCriteria |
| Details |
Patient parent refusing informed consent
Patient parent who speaks language other than Hindi or English
Emergency surgery
Any treatment that affects psychological status
Patient not extubated after surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected Outcome of the proposed study will be to compare the effectiveness of 2 doses dexmedetomidine will decrease emergence agitation in paediatric patients undergoing elective surgeries.
To evaluate effect of dexmedetomidine on MAP , HR , BP , at defined time points. |
2HRS POSTOPERATIVELY
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ii) To compare heart rate (HR), blood pressure(BP), oxygen saturation, end-tidal carbon dioxide, and respiratory rate (RR) at regular intervals and evaluated preoperative anxiety, state of agitation, using the validated and widely used Pead’s scale |
2 HRS POST OPERATIVELY |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
03/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Emergence agitation (EA) has been defined as a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying and moaning . EA may cause physical harms to patient such as bleeding from site of surgery, psychological trauma, and delayed discharge from postanaesthetic care unit .Children display a variety of behaviour during anaesthetic recovery. Emergence agitation in children is a common problem with sevoflurane anaesthesia which include phenomenon such as crying, excitation, agitation, delirium and behavioural disturbances during early emergence from general anaesthesia . This phenomenon must be prevented by providing smooth emergence to paediatric patients. Postoperative emergence agitation is a common complication in paediatric surgery patients, which increases the risk of developing postoperative airway obstruction and respiratory depression. Dexmedetomidine is highly specific α2 agonist and has an analgesic-sparing effect and reduces emergence agitation Dexmedetomidine, , has been shown to prevent emergence delirium and agitation. Administered intravenously, dexmedetomidine is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in intensive care settings, and for the sedation of non-intubated patients prior to or during surgery and other procedures. Recently, dexmedetomidine is known to decrease EA in paediatric and day-care surgery following sevoflurane. However, dexmedetomidine IV after anesthetic induction significantly decreases the occurrence of emergence agitation in children undergoing sevoflurane anesthesia. but its role in preventing post desflurane Emergence Agitation EA has not been elucidated in some studies . |