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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.


 
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