Evaluating Dexmedetomidine versus Ketamine impact on the incidence of postoperative delirium and early cognitive dysfunction in patients undergoing off pump coronary artery bypass grafting

Effect of Dexmedetomidine versus Ketamine on postoperative delirium and early cognitive dysfunction after off pump coronary artery bypass grafting: A prospective randomized study - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080931

Enrollment

Registered

2025-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Interventions

Intervention1: 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 minute

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. Timepoint: 1)CAM-ICU score- Day 3 2)Neuropsychological test battery- Day 7	—

Measure

Time frame

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. Timepoint: 1)CAM-ICU score- Day 3 2)Neuropsychological test battery- Day 7

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Secondary

Measure	Time frame
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. Timepoint: 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.	—

Measure

Time frame

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. Timepoint: 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.

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Countries

India

Contacts

Public ContactDr Pooja Singh

AIIMS Bhopal

pooja.anesth@aiimsbhopal.edu.in9340969292

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026