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CTRI Number  CTRI/2021/11/037735 [Registered on: 01/11/2021] Trial Registered Prospectively
Last Modified On: 01/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   study the effect of dexmedetomidine drug in preventing confusional state and agitation that occurs in patients undergoing brain surgery under general anaesthesia. 
Scientific Title of Study   Comparison of the effect of intraoperative infusion of dexmedetomidine on emergence agitation and delirium in children undergoing craniotomy with total intravenous anaesthesia (TIVA) with propofol – A randomized controlled clinical trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajisheen BorgeoS S 
Designation  Post graduate Registrar in Anaesthesiology 
Affiliation  Christian Medical College,Vellore 
Address  Department of Anesthesiology, Christian Medical College, Vellore,
Department of Anesthesiology, Christian Medical College, Vellore,
Vellore
TAMIL NADU
632004
India 
Phone  9995927960  
Fax    
Email  sheenborgeo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Georgene singh 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anesthesiology, Christian Medical College, Vellore,
Department of Anesthesiology, Christian Medical College, Vellore,
Vellore
TAMIL NADU
632004
India 
Phone  9443292504  
Fax    
Email  georgene@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Georgene singh 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anesthesiology, Christian Medical College, Vellore,
Department of Anesthesiology, Christian Medical College, Vellore,
Vellore
TAMIL NADU
632004
India 
Phone  9443292504  
Fax    
Email  georgene@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Institutional Review Board, Christian Medical College Vellore 
 
Primary Sponsor  
Name  Institutional Review BoardChristian Medical CollegeVellore 
Address  Christian Medical College, Vellore,Bagayam Campus, 632002 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAjisheen Borgeo  Christian Medical College  Neurosurgery theatre, Neurosurgery wards, and Neurosurgical ICU
Vellore
TAMIL NADU 
9995927960

sheenborgeo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine infusion  Intervention arm will receive an infusion of Propofol 150-250 mcg/kg/hr, Fentanyl 1-2 mcg/kg/hr titrated to a BIS of 40-60 without volatile anaesthetic. It will also receive dexmedetomidine infusion at a rate of 0.5mcg/kg/hr as an adjunct to TIVA  
Comparator Agent  Normal Saline as Placebo  Comparator Arm will receive an infusion of Propofol 150-250 mcg/kg/hr, fentanyl 1-2 mcg/kg/hr, titrated to a BIS of 40-60 without volatile anaesthetic It will get 0.5mg/kg/hr infusion of saline as placebo.  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 Paediatric age group patients planned for craniotomy under general anaesthesia will be recruited for the study. 
 
ExclusionCriteria 
Details  1)ASA 3 and above.
2)Known allergy to study drugs.
3)History of renal disease-age appropriate e-GFR criteria
4)History of liver disease.
5)Psychiatric illness
6)Heart block, known case of seizure disorder coming for seizure surgery
7)Patient refusal
8)GCS <15
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Emergence Delirium as assessed by the PAED scale   7 time points,T1-at recovery,T2 after 2 hours of recovery,T3-6 hours,T4-12 hours,T5-24 hours,T6- 36 hours,T7-48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1)Emergence Agitation as assessed by Watcha, Richmond’s agitation sedation scale
2.Intraoperative and Postoperative haemodynamics

3.Recovery characteristics

4.Postoperative Analgesia
 
7 time points,T1-at recovery,T2 after 2 hours of recovery,T3-6 hours,T4-12 hours,T5-24 hours,T6- 36 hours,T7-48 hours 
 
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)   01/11/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   planned to publish after completion. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Emergence agitation and delirium are well-described phenomena during emergence from general anaesthesia, especially in the paediatric population.

Emergence Agitation (EA) is an “unpleasant state of extreme arousal” characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness usually following emergence from General Anaesthesia. The true incidence of EA in children is unclear but has been estimated to be between 10 - 80 %.

Emergence Delirium (ED)  is an altered state of consciousness, which begins with emergence from anesthesia and continues throughout the early recovery period. ED is a disturbance of awareness of, or attention to, the child’s environment, and manifests as disorientation, hyperactive/hypoactive behavior, and hypersensitivity in the immediate period after anesthesia.

Although there is significant ongoing research on the incidence, risk factors, and the probable consequences of EA/ED, neurosurgical procedures have generally been exempt owing to the complexity in differentiation between the neurological conditions and the effect of recovery from anaesthetics.  A study done in the adult neurosurgical population has shown a higher incidence of EA in neurosurgical patients (29%).

Children undergoing craniotomy are more vulnerable to the stress that follows EA/ED. In a recent observational study done in our institution, the incidence of emergence agitation was 28% in the paediatric population undergoing craniotomy.

Total intravenous anaesthetic (TIVA) techniques with propofol, which has been the mainstay of neurosurgical practice have been associated with a reduced incidence of EA/ED in other surgical procedures. However, in children, it is often necessary to use high concentration volatile anaesthetics to induce general anaesthesia before initiation of TIVA as they may not cooperate for intravenous access which predisposes them to develop EA/ED.

Dexmedetomidine is a selective alpha-2 receptor agonist acting on alpha-2 receptors in the locus ceruleous of the pons. Recently, Dexmedetomidine is beneficial in reducing the incidence of EA/ED in children undergoing general anaesthesia. However, there is no literature regarding its use in the paediatric neurosurgical population.

We hypothesize that the use of intravenous dexmedetomidine as an infusion at a dose of 0.5mcg/kg/hr could reduce the incidence of EA/ED in paediatric patients undergoing craniotomy.

 
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