| CTRI Number |
CTRI/2022/07/044425 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To observe acute confusional state in paediatric patients following recovery from general anaesthesia by comparing two different methods of induction of anaesthesia. |
|
Scientific Title of Study
|
A randomised control study to compare two different methods of induction of anaesthesia in paediatric patients and its effect on emergence delirium. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishad Devang Shah |
| Designation |
PG Resident |
| Affiliation |
Krishna Institute of Medical Sciences "Deemed To Be University" ,Karad |
| Address |
Department of Anaesthesiology, Krishna Institute of Medical Sciences "Deemed To Be University" Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
9426493943 |
| Fax |
|
| Email |
shahvishad95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vilas S Kapurkar |
| Designation |
Associate Professor |
| Affiliation |
Krishna Institute of Medical Sciences "Deemed To Be University" ,Karad |
| Address |
Department of Anaesthesiology, Krishna Institute of Medical Sciences "Deemed To Be University" Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
|
| Fax |
|
| Email |
vskapurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vilas S Kapurkar |
| Designation |
Associate Professor |
| Affiliation |
Krishna Institute of Medical Sciences "Deemed To Be University" ,Karad |
| Address |
Department of Anaesthesiology, Krishna Institute of Medical Sciences "Deemed To Be University" Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
|
| Fax |
|
| Email |
vskapurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Institute of Medical Sciences Deemed To Be University |
|
|
Primary Sponsor
|
| Name |
Krishna Institute of Medical Sciences Deemed To Be University |
| Address |
Department of Anaesthesiology, Krishna Institute of Medical Sciences "Deemed To Be University" Karad |
| Type of Sponsor |
Other [Deemed to Be University] |
|
|
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 |
| Vishad Devang Shah |
Krishna Institute of Medical Sciences |
Department of Anaesthesiology
Satara
MAHARASHTRA |
9426493943
shahvishad95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishna Institute of Medical Sciences |
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 |
Ketamine |
2 mg/kg till the loss of Eyelash Reflex. |
| Comparator Agent |
Sevoflurane |
Induction with 8 % and 100% Oxygen till the loss of Eyelash Reflex. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Child with ASA PHYSICAL STATUS 1 and 2 of either Sex.
2) Age 2 to 12 years. |
|
| ExclusionCriteria |
| Details |
1) Known allergies to the drugs used.
2) Child belonging to ASA III and above.
3) Child with a history of any Cardiovascular, respiratory, or central nervous system disorder.
4) Child with Neurological diseases, developmental delay, Airway difficulty. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To measure and compare the incidence of agitation and delirium in paediatric patients after the recovery (i.e., after the discontinuation of anaesthesia) between two methods of induction of anaesthesia, IV induction with Ketamine and Inhalational induction with Sevoflurane using paediatric anaesthesia emergence delirium score. |
To access the Emergence Delirium in the Paediatric Patients using Paediatric Anaesthesia Emergence Delirium Score at 0, 15, 30, 60 and 120 mins. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the ease of mask acceptance.
2. To compare the hemodynamic response between both the types of induction of anaesthesia.
|
1. To assess the ease of mask acceptance while inducing.
2. To compare the hemodynamic response between both the types of induction of anesthesia, After Intubation, 5 min, 10 min, 15 min, 20 min and 25 min.
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sevoflurane is generally the preferred anaesthetic agent for induction and maintenance of general anaesthesia in paediatric patients, including patients with extreme non-cooperation, due to its rapid induction and recovery characteristics. However, it has been recognized that one of the major complications after sevoflurane anaesthesia in paediatric patients is emergence agitation when awakening from general anaesthesia, with the reported incidence ranging between 10% and 80%.
Emergence agitation is recognized as a major risk factor for significant complications, such as anxiety, eating and sleeping disorders, and enuresis, along with persistent secondary alteration of emotional and cognitive development. Furthermore, the prolonged postoperative severe agitation might be another major complication for safety management of these patients. These have negative implications from a hospital management point of view, and also cause a decline in patient satisfaction and that of their families due to the potential for self-injury and other injurious behaviours, and are a burden on nursing staff.
As it is more stressful for both patients, parents as well as medical and nursing staff we have devised this study to evaluate whether any change in the technique of anaesthesia induction could possibly lower the incidence of ED. |