Hypotension Clinical Trial
Official title:
Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study
NCT number | NCT01006863 |
Other study ID # | 28/2004 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2004 |
Est. completion date | March 2010 |
Verified date | August 2020 |
Source | King Faisal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The prophylactic use of small doses of ephedrine may be effective in obtunding of the
hypotension responses to propofol with minimal hemodynamic and ST segment changes. The
investigators aimed to evaluate the effects of small doses of ephedrine on hemodynamic
responses of propofol anesthesia for valve surgery.
There is widespread interest in the use of propofol for the induction and maintenance of
anesthesia for fast track cardiac surgery. However, its use for induction of anesthesia is
often associated with a significant rate related transient hypotension for 5-10 minutes. This
is mainly mediated with decrease in sympathetic activity with minor contribution of its
direct vascular smooth muscle relaxation and direct negative inotropic effects.
Ephedrine has demonstrated as a vasopressor drug for the treatment of hypotension in
association with spinal and general anesthesia. Prophylactic use of high doses of ephedrine
[10-30 mg] was effective in obtunding the hypotensive response to propofol with associated
marked tachycardia. However, the use of smaller doses (0.1-0.2 mg/kg) was successfully
attenuated, but not abolished, the decrease in blood pressure with transient increase in
heart rate. This vasopressor effect is mostly mediated by β-stimulation rather than
α-stimulation and also indirectly by releasing endogenous norepinephrine from sympathetic
nerves.
Because the effect of decreasing the dose of ephedrine from 0.1 to 0.07 mg/kg may be
clinically insignificant, the investigators postulated that the prophylactic use of small
dose of ephedrine may prevent propofol-induced hypotension after induction of anesthesia for
valve surgery with minimal in hemodynamic, ST segment, and troponin I changes.
The aim of the present study was to investigate the effects of pre-induction administration
of 0.07, 0.1, 0.15 mg/kg of ephedrine on heart rate (HR), mean arterial blood pressure (MAP),
central venous and pulmonary artery occlusion pressures (CVP and PAOP, respectively), cardiac
(CI), stroke volume (SVI), systemic and pulmonary vascular resistance (SVRI and PVRI,
respectively), left and right ventricular stroke work (LVSWI and RVSWI, respectively)
indices, ST segment, and cardiac troponin I (cTnI) changes in the patients anesthetized with
propofol-fentanyl for valve surgery.
Status | Completed |
Enrollment | 150 |
Est. completion date | March 2010 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - One hundred fifty ASA III-IV patients - aged 18-55 years - scheduled for elective valve surgery Exclusion Criteria: - Patients with documented un-controlled hypertension -ischemic heart disease- - left ventricular ejection fraction less than 45% - peripheral vascular disease - thyrotoxicosis - neurological - hepatic - renal diseases - pregnancy - re-do or emergency surgery - allergy to the study medications - those requiring preoperative inotropic, vasopressor or mechanical circulatory or ventilatory support - those who had electrocardiograph (ECG) characteristics that would interfere with ST segment monitoring, included baseline ST segment depression, left bundle-branch block, atrial fibrillation, left ventricular hypertrophy, digitalis effect, QRS duration >0.12 s, as well as pacemaker-dependent rhythms, |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University Hospitals | Mansoura | DK |
Saudi Arabia | King Fahd Hospital of the University | Dammam | Eastern |
Lead Sponsor | Collaborator |
---|---|
King Faisal University | Mansoura University |
Egypt, Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome variables include the changes in hemodynamic variables namely; MAP, SVRI, CI, HR, LVSWI, and ST segment changes. | before (baseline), and 5 min after induction, 5, 10, 15, and 30 min after endotracheal intubation; and 15 min after sternotomy. | ||
Secondary | Secondary outcome variables were outcome data, troponin I changes, and the need for vasoactive drugs. | cardiac troponin I. measured at before, 3, 12, 24, and 48 hours after CPB |
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