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CTRI Number  CTRI/2025/02/080931 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluating Dexmedetomidine versus Ketamine impact on the incidence of postoperative delirium and early cognitive dysfunction in patients undergoing off pump coronary artery bypass grafting 
Scientific Title of Study   Effect of Dexmedetomidine versus Ketamine on postoperative delirium and early cognitive dysfunction after off pump coronary artery bypass grafting: A prospective randomized study  
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 Divyanshi Agarwal 
Designation  Junior Resident 
Affiliation  AIIMS Bhopal 
Address  Department of Anaesthesiology and Department of cardiothoracic and vascular surgery 3rd floor, Hospital building AIIMS Saket Nagar, Bhopal.

Bhopal
MADHYA PRADESH
462020
India 
Phone  09258442507  
Fax    
Email  divyanshia2014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pooja Singh 
Designation  Additional Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anaesthesiology and Department of cardiothoracic and vascular surgery 3rd floor, Hospital building AIIMS Saket Nagar, Bhopal. Madhya Pradesh

Bhopal
MADHYA PRADESH
462020
India 
Phone  9340969292  
Fax    
Email  pooja.anesth@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pooja Singh 
Designation  Additional Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anaesthesiology and Department of cardiothoracic and vascular surgery 3rd floor, Hospital building AIIMS Saket Nagar, Bhopal. Madhya Pradesh

Bhopal
MADHYA PRADESH
462020
India 
Phone  9340969292  
Fax    
Email  pooja.anesth@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhopal, Madhya Pradesh, India, 462020 
 
Primary Sponsor  
Name  Dr Pooja Singh 
Address  Department of Anesthesiology,AIIMS Bhopal,Saket Nagar, Bhopal,Madhya Pradesh, India, 462020 
Type of Sponsor  Other [Guide(Additional Professor)] 
 
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 Divyanshi Agarwal  All India Institute of Medical Sciences Bhopal  Department of Anaesthesiology 3rd floor, Hospital building All India Institute of Medical Sciences Bhopal, Saket Nagar, Bhopal. Madhya Pradesh
Bhopal
MADHYA PRADESH 
9258442507

divyanshia2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhopal Institutional Human Ethics Committee- Student Reseaerch(IHEC-SR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infusion Dexmedetomidine (Group D) Infusion Ketamine (Group K)  Group D- Patients will recieve continuous infusion of injection dexmedetomidine @5ml/hr(0.5mcg/kg/hr),starting 10 minutes after induction till the end of surgery. Group K-Patients will receive continuous infusion of injection ketamine @5ml/hr (0.3mg/kg/hr) starting 10 minutes after induction till the end of surgery. 
Comparator Agent  Infusion Normal Saline  Group S-Patients will receive continuous infusion of normal saline @5ml/hr starting 10 minutes after induction till the end of surgery. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1)Patients of age 45-85 years of age, of either sex, with ASA physical status 1-3.
2)Patients with triple vessel disease.
3)Patients scheduled for elective off pump coronary artery bypass grafting. 
 
ExclusionCriteria 
Details  1.Not willing to participate
2.Emergency Off pump coronary artery bypass grafting.
3.Intraoperative conversion of Off pump coronary artery bypass grafting to on-pump coronary artery bypass grafting.
4.Ejection Fraction less than 30%
5.Prior cardiac surgery/ Redo surgery
6.History of stroke with residual deficit
7.Preoperative MMSE less than 24
8.Any congenital/acquired cerebrovascular/neurological disorder
9.Alcohol and substance abuse
10.Severe bradycardia, heart block
11.Allergy to study drugs.
 
 
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 
1.Postoperative delirium will be assessed through Confusion Assessment Method (CAM-ICU) (Annexure 3) scoring on 3rd postoperative day; with scoring of 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
2.Postoperative Cognitive Dysfunction will be assessed on 7th postoperative day through four neuropsychological tests (Rey auditory verbal test, Trail making A and B test, Stroop colour word interference test, Letter digit coding test). Patient will be diagnosed with cognitive dysfunction if the composite Z score will be 1.96 or more, from the composite Z score one day before surgery or when the patient had two Z scores in individual tests at one week.
 
1)CAM-ICU score- Day 3
2)Neuropsychological test battery- Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
1.Intraoperative heart rate, mean arterial pressure and oxygen saturation will be noted before induction (T0), after induction (T1), 15 minutes after starting intervention drugs (T2), before starting coronary grafting (T3), after coronary grafting completion (T4), at the end of surgery (T5).
2.Postoperative complications such as bleeding requiring blood products transfusion or re-exploration, hypotension (mean arterial pressure less than 60mmHg), hypoxemia (oxygen saturation less than 90 %) will be noted. Duration of ICU stay (from the time of arrival to ICU till shifting to ward) and length of hospital stay (from the day of surgery till the discharge of patient from the hospital) will also be noted.
 
T0-Before induction
T1-After induction
T2-15 minutes after starting intervention drugs.
T3-Before starting coronary grafting.
T4-After coronary grafting completion.
T5-At the end of surgery.

During the entire postoperative period till the discharge of the patients from the hospital.
 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   Phase 4 
Date of First Enrollment (India)   28/02/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Delirium is defined as a disturbance in attention, cognition, and/or awareness that develops over a short period, has a fluctuating course, and is accompanied by a change in cognition. Post-operative delirium (POD) can occur from 10 minutes after anesthesia to up to 7 days in the hospital or until discharge. In cardiac surgery patients, the incidence is between 26% and 52%. Postoperative cognitive dysfunction (POCD), characterized by impairment of attention, concentration, and memory with possible long-term implications, is a frequent neurological sequela following cardiac surgery. A retrospective study demonstrated that coronary artery bypass grafting (CABG) is the most common cause of POCD after a cardiac operation with an incidence of 37.6% in 7 days and 20.8% in the 3rd month of the postoperative period.

Dexmedetomidine a highly potent α2-agonist is used widely in critical care for control of delirium. Further, there is some evidence that ketamine which is a N-methyl-D-aspartic acid (NMDA) antagonist might also be an option to reduce the risk of POD and POCD in surgical patients.

Although several pharmacological agents have been studied individually, but these are not compared in terms of efficacy in reducing cognitive dysfunction after cardiac surgeries till date.

 

Our primary objective is 1) To determine the difference in the CAM-ICU score among group D, group K, and group S, on 3rd postoperative day using CAM-ICU (Confusion Assessment Method) scoring for delirium in patients undergoing elective off-pump coronary artery bypass grafting. 2)To determine the changes in the neuropsychological test scores between group D, group K and group S, on 7th postoperative day using composite Z score of four neuropsychological tests in patients undergoing elective off-pump coronary artery bypass grafting. We will also compare the incidence of POD and POCD, hemodynamic stability, time of extubation, duration of ICU and hospital stay, in both the groups.

 

Patients aged 45-85 years, of either sex belonging to American Society of Anesthesiologists physical status class I, II & III, posted for elective OPCAB surgery will be enrolled over a period of 18 months. Preoperative Mini-mental state examination (MMSE) will be used as a screening tool. Patients with MMSE<24 will be excluded. Baseline cognitive evaluation will be conducted using a battery of neuropsychological tests for comprehensive preoperative assessment of the cognitive status including memory, attention, language, executive function, and motor speed. These tests are Rey auditory verbal learning test ,Trail-making A and B test, Stroop color interference test, Letter Digit coding test. All the included patients will be randomized into three groups using computer generated random number through a software. Group D: Patients will receive continuous infusion of injection Dexmedetomidine @ 5ml/hr (0.5µg/kg/h), Group K:  Patients will receive continuous infusion of injection Ketamine @5ml/hr (0.3mg/kg/h) ,Group S: Patients will receive continuous infusion of normal saline @5ml/hr .The infusions will be started 10 minutes after the induction and after ensuring stable hemodynamic and will be continued till the end of surgery. The patients will be assessed on 3rd postoperative day for delirium and 7th day for cognitive dysfunction.

 

Assessment of outcomes will be done as follows.1)Postoperative delirium will be assessed through Confusion Assessment Method (CAM-ICU) (Annexure 3) scoring on 3rd postoperative day; with scoring of 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. 2)Postoperative Cognitive Dysfunction will be assessed on 7th postoperative day through four neuropsychological tests (Rey auditory verbal test, Trail making A and B test, Stroop color word interference test, Letter digit coding test). Patient will be diagnosed with cognitive dysfunction if the composite Z score will be 1.96 or more, from the composite Z score one day before surgery or when the patient had two Z scores in individual tests at one week. Assessment of secondary outcomes will be done as follows. Intraoperative heart rate, mean arterial pressure and oxygen saturation will be noted .Duration of ICU stay (from the time of arrival to ICU till shifting to ward) and length of hospital stay (from the day of surgery till the discharge of patient from the hospital) will also be noted.

 

                                               

 

 

 
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