| 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
|
|
|
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
|
|
|
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. |
|
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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. |