Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

Intravenous Clonidine Does Not Reduce Pulmonary Artery Pressure in Patients Subjected to Cardiac

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01597427

Enrollment

Registered

2012-05-14

Start date

2009-03-31

Completion date

2012-03-31

Last updated

2012-05-14

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

Conditions

Anesthesia

Keywords

Clonidine, Hypertension Pulmonary, Cardiac Surgical Procedures

Brief summary

The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.

Detailed description

Prospective, clinical-interventionist, randomized, and double-blind study. Patients with group 2 pulmonary hypertension will be included and subjected to cardiac surgery with extracorporeal circulation. Mean pulmonary artery pressure and the doses of dobutamine and sodium nitroprusside will be assessed four times: before (T0) administration of 2 μg/kg of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after extracorporeal circulation (T2), and 10 minutes after the injection of protamine (T3).

Interventions

DRUGClonidine

Administration of 2 μg/kg of intravenous clonidine

DRUGPlacebo

Injection of placebo solution.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Signing an informed consent form, * Aged 18 to 80 years * Pulmonary hypertension due to left heart disease, * Physical status 2 or 3 according to the classification system of the American Society of Anesthesiologists, * Subjected to cardiac circulation with extracorporeal circulation

Design outcomes

Primary

Measure	Time frame	Description
Reduction pulmonary artery pressure	During intraoperative (hours)	Assessed four times: before (T0) administration of 2 μg·kg-1 of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after ECC (T2), and 10 minutes after the injection of protamine (T3).

Secondary

Measure	Time frame	Description
Doses of Dobutamine	During intraoperative (hours)	Evaluate the need for using and dose of dobutamine immediately after extracorporeal circulation between groups.
Doses of Sodium nitroprusside	During intraoperative (hours)	Evaluate the need for using and dose of sodium nitroprusside immediately after extracorporeal circulation between groups.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026