Effect of Dexmedetomidine on Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome (CABAG)

Ain Shams University

Status and phase: Enrolling; Early Phase 1

Conditions: Effect of Drug in CABAG Patients

Treatments: Other: normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05778305

FMASU MD283/2022

Details and patient eligibility

About

50 patients of both sexes undergoing elective CABG surgery will be randomly divided into 2 groups, study group (Dex) group and control group (C) to determine the effect of dexmedetomidine on the peri-operative hemodynamic changes during CABG surgery.

Full description

The effect of dexmedetomidine during CABG surgery is studied regarding Ventricular function, pre bypass and post bypass using the transoeophageal echo (TEE), post-operative by transthoracic echocardiography (TTE) on day of surgery and after extubation.

Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing elective CABG surgery

Exclusion criteria

• Patient refusal

  • Dementia patients
  • Poor ventricular function with ejection fraction below 40%
  • Asthmatic patients
  • Uncontrolled diabetic patients with HbA1c above 8
  • Combined surgeries (CABG+ valves)
  • Emergency surgeries.
  • Pre-existing arrhythmia
  • Patients with renal impairment
  • Patients with hepatic impairment
  • Patients with heart block
  • Off-pump CABG

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Active Comparator group

Description:

patients will have loading Dexmedetomidine( 1ug/kg) over 10 minutes followed by continuous infusion of (0.5ug/kg/hr) from the initiation of anaesthesia up to extubation in the ICU. Patients will not be extubated until completely awake and have no sign of arrhythmias and bleeding

Treatment:

Drug: Dexmedetomidine

control group

Placebo Comparator group

Description:

patients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion.

Treatment:

Other: normal saline