Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in CABG

NCT05218161 | Unknown

• 2 other identifiers: CPEIC No. 153153
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In post cardiac surgery, many cardiovascular and other complications may occur that lead to increase in mortality and hospital stays. Meticulous perioperative management is important to avoid these adverse events. Tachycardia is the main cause of post coronary artery bypass graft (CABG) myocardial ischemia which can be decreased by sedation and analgesia.

Conditions

Hemodynamic Instability

Keywords

Cardiac Surgery; Dexmedetomidine; Extubation; Hemodynamics; Ketamine; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Hemodynamic stability

  Hemodynamic stability:If blood pressure and heart rate are with in appropriate limits,it will be considered as hemodynamically stable. Blood pressure:MAP\>65 mmhg is considered stable. Heart rate:80-100 bpm is considered stable.

  06 months

Study Arms (2)

DA

ACTIVE COMPARATOR

Group DA: will be assigned to patients in whom dexmedetomidine alone will be used.

Drug: Dexmedetomidine alone

KD

EXPERIMENTAL

Group KD: will be assigned to patients receiving ketamine plus dexmedetomidine.

Drug: Dexmedetomidine alone

Interventions

Dexmedetomidine alone DRUG

All the patients in group DA will be sedated using dexmedetomidine 1mcg/kg IV bolus, followed by 0.3-0.7mcg/kg/h infusion to maintain Ramsay sedation score ≥4 during assisted ventilation.

DA; KD

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of 40-60 years old Hemodynamically stable with normal or moderately impaired left ventricular function Ejection fraction \>40% that underwent elective surgery CABG surgery for single vessel

You may not qualify if:

• Hemodynamic instability intraoperative. Patients on moderate to high vasopressors or ionotropes. Ejection fraction less than 40%. Off pump surgery. Patient on mechanical supports.

Sponsors & Collaborators

• Chaudhry Pervaiz Elahi Institute of Cardiology: lead

Study Sites (1)

CPEIC

Multan, Pakistan

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr Shumaila Rai, FCPS

  Chaudhry Pervaiz Elahi Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant anesthetist

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 1, 2022
• Study Start: January 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)