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Comparison of Intraoperative Awareness with Dexmedetomidine–Propofol Infusion versus Intravenous Xylocaine–Propofol Infusion in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Trial

Protocol summary

Study aim
To compare the effectiveness of dexmedetomidine plus propofol infusion versus intravenous xylocaine (lidocaine) plus propofol infusion in preventing intraoperative awareness among patients undergoing elective coronary artery bypass grafting (CABG) under general anesthesia.
Design
RCT
Settings and conduct
National hospital lahore
Participants/Inclusion and exclusion criteria
Patients aged 30–75 years, of either gender. Scheduled for elective isolated CABG under general anesthesia. ASA physical status III–IV. LVEF ≥35%. Able to provide written informed consent and complete the Modified Brice Interview postoperatively. Exclusion Criteria Emergency or combined cardiac surgery, or previous cardiac surgery. Allergy or contraindication to dexmedetomidine, propofol, or lidocaine. Neurological or psychiatric disorders affecting awareness assessment. Chronic use of sedatives, opioids, alcohol, or recreational drugs. Severe hepatic or renal disease, significant heart block/bradycardia, or need for preoperative mechanical circulatory/ventilatory support. Inability to complete postoperative interviews, or pregnancy/lactation.
Intervention groups
Patients in the intervention group will receive dexmedetomidine (1 µg/kg loading dose over 10 minutes, followed by 0.2–0.7 µg/kg/hour infusion) along with propofol infusion for maintenance of anesthesia during elective CABG. Propofol will be titrated according to the institutional anesthesia protocol to maintain an adequate depth of anesthesia. Standard intraoperative monitoring and anesthetic management will be the same for both groups.
Main outcome variables
Primary Outcome Variable Intraoperative awareness, assessed using the Modified Brice Interview at 24 and 72 hours after surgery.

General information

Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20240901062926N2
Registration date: 2026-07-20, 1405/04/29
Registration timing: registered_while_recruiting

Last update: 2026-07-20, 1405/04/29
Update count: 0
Registration date
2026-07-20, 1405/04/29
Registrant information
Name
Muhammad Tayyeb
Name of organization / entity
Superior University
Country
Pakistan
Phone
+92 307 8625941
Email address
tayyabm851@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-22, 1405/02/02
Expected recruitment end date
2026-07-25, 1405/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Intraoperative Awareness with Dexmedetomidine–Propofol Infusion versus Intravenous Xylocaine–Propofol Infusion in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Trial
Public title
Intraoperative Awareness with Dexmedetomidine–Propofol Infusion versus Intravenous Xylocaine–Propofol Infusion in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients aged 30–75 years. Patients of either gender.Patients scheduled for elective isolated Coronary Artery Bypass Grafting (CABG) under general anesthesia American Society of Anesthesiologists (ASA) physical status III or IV.Left ventricular ejection fraction (LVEF) ≥35% Patients who are able to understand the study protocol and provide written informed consent. Patients who are able to communicate postoperatively and complete the Modified Brice Interview.
Exclusion criteria:
Patients undergoing emergency CABG surgery.Patients scheduled for combined cardiac procedures (e.g., CABG with valve replacement or other cardiac surgeries).History of previous cardiac surgery (redo CABG).Known hypersensitivity or contraindication to dexmedetomidine, propofol, lidocaine (xylocaine), or any study medication.Pre-existing neurological disorders (e.g., stroke with cognitive impairment, epilepsy, dementia) or psychiatric illnesses that may interfere with the assessment of awareness.Chronic use of sedatives, opioids, alcohol, or recreational drugs.Severe hepatic dysfunction (Child–Pugh Class C) or severe renal impairment requiring dialysis.Significant conduction abnormalities (e.g., second- or third-degree atrioventricular block without a permanent pacemaker) or severe bradycardia (heart rate <50 beats/min).Patients requiring preoperative mechanical ventilation or intra-aortic balloon pump support.Patients with hearing impairment, language barriers, or inability to participate in postoperative interviews.Pregnant or lactating women.
Age
From 30 years old to 75 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients who provide written informed consent will be randomly allocated in a 1:1 ratio to either the Dexmedetomidine Propofol group (Group D) or the Xylocaine–Propofol group (Group X) using a computer-generated randomization sequence. Group allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened immediately before induction of anesthesia by an anesthesiologist not involved in postoperative outcome assessment. This process will ensure unbiased allocation of participants to the two study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as a single-blinded randomized controlled trial. The participants will be unaware of the treatment group to which they are assigned (Dexmedetomidine–Propofol or Intravenous Xylocaine–Propofol). An anesthesiologist who is not involved in data collection will prepare and administer the study medications according to the randomization sequence. The investigator responsible for postoperative assessment of intraoperative awareness using the Modified Brice Interview and data analysis will remain blinded to the group allocation. The anesthesiologist administering anesthesia cannot be blinded due to the differences in drug preparation and administration protocols. This blinding approach is intended to minimize assessment bias while ensuring patient safety throughout the perioperative period.
Placebo
Not used
Assignment
Parallel
Other design features
none

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
NATIONAL HOSPITAL & MEDICAL CENTER
Street address
national hospital
City
lahore
Postal code
2246
Approval date
2025-05-25, 1404/03/04
Ethics committee reference number
REF: NHMC/IRB/114

Health conditions studied

1

Description of health condition studied
Intraoperative awareness is the unintended recall of events experienced during general anesthesia. It is a rare but serious complication that can result in psychological distress, anxiety, sleep disturbances, and post-traumatic stress disorder (PTSD). Patients undergoing coronary artery bypass grafting (CABG) are at a higher risk of intraoperative awareness because anesthetic doses are often reduced to maintain cardiovascular stability. This study aims to compare the effectiveness of dexmedetomidine–propofol infusion versus intravenous xylocaine–propofol infusion in reducing the incidence of intraoperative awareness in patients undergoing elective CABG.
ICD-10 code
Y93
ICD-10 code description
Activity codes

Primary outcomes

1

Description
Intraoperative awareness, assessed using the Modified Brice Interview conducted at 24 hours and 72 hours after surgery. Patients reporting explicit recall of intraoperative events will be considered to have experienced intraoperative awareness.
Timepoint
24 hour and 72 hours
Method of measurement
Modified Brice Interview Interpretation0 No intraoperative awareness (no explicit recall of intraoperative events).1 Possible intraoperative awareness (uncertain or vague recall requiring further evaluation).2 Definite intraoperative awareness (clear explicit recall of intraoperative events).Interpretation:0: No awareness1: Possible awareness2: Definite awareness

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
NATIONAL HOSPITAL & MEDICAL CENTER
Full name of responsible person
Dr. Ahmad Tariq
Street address
national hospital
City
lahore
Postal code
2246
Phone
+92 333 4699734
Fax
+92 333 4699734
Email
drahmed6196@gmail.com
Web page address
https://nationalhospital.org/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Hospital & Medical Center
Full name of responsible person
National Hospital & Medical Center
Street address
national hospital
City
lahore
Postal code
2246
Phone
+92 307 8625941
Fax
+92 307 8625941
Email
tayyabm851@gmail.com
Web page address
https://nationalhospital.org/
Grant name
https://nationalhospital.org/
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Hospital & Medical Center
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
National Hospital & Medical Center
Full name of responsible person
Dr Ahmad Tariq
Position
consultant
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
national hospital
City
lahore
Province
Punjab
Postal code
2246
Phone
+92 307 8625941
Fax
+92 307 8625941
Email
drahmed6196@gmail.com
Web page address
https://nationalhospital.org/

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Hospital & Medical Center
Full name of responsible person
Dr Ahmad Tariq
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
national hospital
City
lahore
Province
Punjab
Postal code
2246
Phone
+92 307 8625941
Fax
+92 307 8625941
Email
drahmed6196@gmail.com
Web page address
https://nationalhospital.org/

Person responsible for updating data

Contact
Name of organization / entity
National Hospital & Medical Center
Full name of responsible person
Dr Ahmad Tariq
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
national hospital
City
lahore
Province
Punjab
Postal code
2246
Phone
+92 307 8625941
Fax
+92 307 8625941
Email
drahmed6196@gmail.com
Web page address
https://nationalhospital.org/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
DATA
When the data will become available and for how long
6 month
To whom data/document is available
open access
Under which criteria data/document could be used
educational purpose
From where data/document is obtainable
National Hospital
What processes are involved for a request to access data/document
email
Comments
thankful
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