Dexmedetomidine vs Lignocaine for Reducing Intubation-Induced Hemodynamic Responses in Cardiac Surgery: A Randomized Controlled Trial

Rawalpindi Institute of Cardiology

Status and phase: Enrolling; Phase 4

Conditions: Laryngoscopic Stress Response; Dexmedetomidine; Lignocaine

Treatments: Drug: IV Lignocaine; Drug: IV dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07611890

RIC/RERC/13/25

Details and patient eligibility

About

After confirming eligibility, written informed consent will be obtained by a trained team member who is not involved in assigning treatment or giving the study medication. Each participant will receive a unique study number to protect privacy. Participants will be randomly assigned to receive one of the study medications using a chance-based method.The study medication will be administered through a vein before placement of the breathing tube. Blood pressure and pulse rate will be measured before the procedure and at several time points after the breathing tube is inserted.

Full description

After confirming eligibility, written informed consent will be obtained and each participant will be assigned a unique study ID to maintain confidentiality. Participants will be randomly allocated using a computer-generated random sequence implemented through the lottery method, with assignments placed in sealed opaque envelopes opened on the day of surgery. The study medication will be administered intravenously according to the study protocol before laryngoscopy and endotracheal intubation. Mean arterial pressure and heart rate will be recorded at baseline and at 1, 3, 5, and 10 minutes after intubation. Demographic information and study-related observations will be documented in a structured data collection form.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

American Society of Anesthesiologists (ASA) physical status III-IV. Patients who are at risk of cardiovascular events

Exclusion criteria

1. Patients with known hypersensitivity to dexmedetomidine and Lignocaine.
2. Patients on medications that could interfere with the study (e.g., beta-blockers, calcium channel blockers).
3. Pregnant or lactating women.
4. Patients with a history of airway anomalies or difficult intubation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Group Dexmed

Active Comparator group

Treatment:

Drug: IV dexmedetomidine

Group Lignocaine

Active Comparator group

Treatment:

Drug: IV Lignocaine