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CTRI Number  CTRI/2021/09/036789 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 15/09/2021
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 urological surgery under general anaesthesia. 
Scientific Title of Study   Intraoperative Infusion of Dexmedetomidine For The Prevention of Postoperative Delirium In Patients Undergoing Elective Urological Surgery under General Anaesthesia : A Randomised Clinical Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tony Mathew 
Designation  Postgraduate Registrar in Anaesthesiology 
Affiliation  Christian Medical College, Vellore 
Address  Department of Anaesthesiology, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  7508488133  
Fax    
Email  tonyjosef.93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Georgene Singh 
Designation  Professor  
Affiliation  Christian Medical College, Vellore  
Address  Department of Anaesthesia Christian Medical College,Vellore

Vellore
TAMIL NADU
632004
India 
Phone    
Fax    
Email  georgene@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Georgene Singh 
Designation  Professor  
Affiliation  Christian Medical College, Vellore  
Address  Department of Anaesthesia Christian Medical College,Vellore

Cuddalore
TAMIL NADU
632004
India 
Phone    
Fax    
Email  georgene@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Institutional Review Board 
 
Primary Sponsor  
Name  Institutional Review Board IRB 
Address  BAGAYAM CAMPUS: Office of Research,1st Floor, Carman Block, Bagayam, Vellore 632 002 
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 
Dr Tony Mathew  Christian Medical College , Vellore Tamil Nadu - 632004  Urology Operating Room, PACU , Urology Ward and ICU
Vellore
TAMIL NADU 
7508488133

tonyjosef.93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine   Group A – Standard Anaesthetic Protocol and Dexmedetomidine bolus of 0.5 mcg/kg followed by an infusion of 0.3 mcg/kg /hr to a BIS of 40-60 till the end of surgery. 
Comparator Agent  Normal Saline  Group B - Standard Anaesthetic Protocol and Placebo bolus of 0.5 mcg/kg followed by 0.3 mcg/ kg/hour , to a BIS of 40-60 till the end of surgery. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA 1,2 and 3 , Ages 17 to 65 Undergoing Urological Procedures under general anesthesia with endotracheal intubation. 
 
ExclusionCriteria 
Details  ASA 4 and above , Heart block , Preoperative bradycardia of Heartrate < 50.
Psychiatric Illness and use of antipsychotics.
Known allergy to dexmedetomidine.
Pre operative Delerium assessed by a positive CAM.
Patient refusal. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative Delirium as assessed by CAM - ICU / CAM Score  7 Time points.T1-At recovery,T2-After 2 hours of recovery,T3-12 hours,T4-24 hours,T5-36hours,T6-48hours,T7-72 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
Introperative Haemodynamics
Recovery Profile
Postoperative Pain 
7 Time points.T1-At recovery,T2-After 2 hours of recovery,T3-12 hours,T4-24 hours,T5-36hours,T6-48hours,T7-72 Hours 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   01/10/2021 
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   Plan to publish after completion of trial. CTRI approval and recruitment awaited. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The brain is vulnerable during the perioperative period among patients of all ages. Neu- robehavioral disturbances are among the commonly seen postoperative complications, of which three distinct forms are identiYied: emergence delirium, postoperative cognitive decline and the most severe form—postoperative delirium (POD).
POD manifests in patients who have undergone surgical procedures and anaesthesia, usually peaking between 1 and 3 days post surgery.
In the Indian population, POD is not uncommon following major abdominal surgery with its incidence ranging between 5 and 51%. In the urological population, it varies between 7.8- 30%.
In addition to causing physical harm to the patient, POD also causes major inconveniences in providing care to the postoperative surgical patient and seriously impacts both short and long term postoperative outcomes. It is often associated with an increase in hospital stay ,need for admission to a higher level of care , cognitive decline and even increased mortality and wors- ening quality of care.
The risk factors for developing POD are older age, cognitive impairment, severity of illness, psychopathological symptoms, preoperative depression, psychotropic drug use, greater co- morbidity, and perioperative complications. Patients undergoing urological procedures are of- ten old with multiple comorbidities and subclinical sepsis predisposing them to the develop- ment of POD .
Dexmedetomidine serves as a potent sedative with positive sedation and analgesic effects , anxiolytic ability, minimal respiratory depression, haemodynamic stability and prevention of neurotoxicity .The mechanism of dexmedetomidine is related to its highly selective stimula- tion of the alpha-2 adrenoreceptors.
Recent studies have shown that the use of dexmedetomidine is associated with the reduction of POD in patients in ICU and in the postoperative period especially in the cardiac population and the elderly.
We hypothesize that the use of dexmedetomidine in the intraoperative period along with the standard anaesthetic protocol of Balanced Anaesthesia will decrease the incidence of POD and provide stable intraoperative haemodynamics , better recovery profile and pain relief in the postoperative surgical population.
 
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