| 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
|
|
|
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
|
|
|
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. |