| CTRI Number |
CTRI/2020/02/023660 [Registered on: 28/02/2020] Trial Registered Prospectively |
| Last Modified On: |
13/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
To assess the incidence of emergence delirium in children
undergoing elective surgical procedures under General Anesthesia. |
|
Scientific Title of Study
|
A prospective, observational study to assess the incidence of Emergence Delirium in
Pediatric patients undergoing elective surgical procedures under General Anesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHRIS MARIA JOSEPH |
| Designation |
Post doctoral Fellow in Advanced Clinical Anesthesia and Peri-operative Medicine |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE , VELLORE |
| Address |
DEPARTMENT OF ANAESTHESIA
CMC VELLORE
Vellore TAMIL NADU 632004 India |
| Phone |
8146194105 |
| Fax |
|
| Email |
chrismaria23.nmj@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
ANITA SHERLY |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE , VELLORE |
| Address |
DEPARTMENT OF ANAESTHESIA
CMC VELLORE
Vellore TAMIL NADU 632004 India |
| Phone |
7358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
CHRIS MARIA JOSEPH |
| Designation |
Post doctoral Fellow in Advanced Clinical Anesthesia and Peri-operative Medicine |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE , VELLORE |
| Address |
DEPARTMENT OF ANAESTHESIA
CMC VELLORE
Vellore TAMIL NADU 632004 India |
| Phone |
8146194105 |
| Fax |
|
| Email |
chrismaria23.nmj@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL REVIEW BOARD, MEDICAL RESEARCH SECTION |
|
|
Primary Sponsor
|
| Name |
INSTITUTIONAL REVIEW BOARD |
| Address |
INSTITUTIONAL REVIEW BOARD, RESEARCH SECTION OFFICE, CHRISTIAN MEDICAL COLLEGE, VELLORE |
| 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 |
| CHRIS MARIA JOSEPH |
CHRISTIAN MEDICAL COLLEGE |
MAIN OR,DEPARTMENT OF ANAESTHESIA
CHRISTIAN MEDICAL COLLEGE, VELLORE Vellore TAMIL NADU |
8146194105
chrismaria23.nmj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
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
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients (age 2years-18years)
Elective surgical procedures
ASA 1 & 2
|
|
| ExclusionCriteria |
| Details |
Less than 2 years
ASA 3, 4
Obese (BMI more than 30)
Emergency surgeries
Developmental delay
On psychotropic medicines
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the incidence of emergence delirium among pediatric patients undergoing general anesthesia for elective surgical procedures
|
Immediately at the end of surgery and 15 minutes thereafter up to 45 minutes in post anaesthesia care unit.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the possible risk factors associated with emergence delirium in our population such as age, duration of pre operative fasting, pre medication
administered, parental presence, duration of surgery and post operative pain scores. |
During pre operative evaluation and intra operative period. |
|
|
Target Sample Size
|
Total Sample Size="190" Sample Size from India="190"
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)
|
02/03/2020 |
| 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)
|
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)?
|
|
Brief Summary
|
Emergence agitation (EA) has been defined as a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning or incoherent. The average estimated incidence of emergence delirium is between 18-30%. The risk factors involved
in emergence delirium include anaesthetic factors such as the type of the agent used, presence of post operative
pain and time taken for emergence from anaesthesia. Patient factors such as their age, period of preoperative fasting,
presence of anxiety and parental anxiety also contribute to emergence delirium
along with the type of surgical procedure being performed. Although the term emergence agitation has been limited to the post operative period, study done by Levy et al has shown that these children exhibit behavioural changes well beyond the recovery period from general anaesthesia. As stated above in the definition of emergence delirium, includes any such behaviour as thrashing, uncooperative behaviour which can put the patient and healthcare provider at a risk of injury. Any injury to the patient at the surgical site doubles the duration of hospital stay and cost involved in their treatment. The studies done previously have shown that inhalational agents such as halothane, isoflurane, desflurane and sevoflurane have contributed to emergence delirium. However sevoflurane has been found to been the greatest contributor of emergence delirium in children . Hence we undertake this study to further decipher the incidence of emergence delirium in our population using sevoflurane followed by isoflurane.
|