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Coronary Blood Flow Regulation During General Anesthesia

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ClinicalTrials.gov Identifier: NCT00866801
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by (Responsible Party):
C.S.E. Bulte, Amsterdam UMC, location VUmc

Tracking Information
First Submitted Date March 20, 2009
First Posted Date March 23, 2009
Last Update Posted Date October 14, 2015
Study Start Date April 2009
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2009)		 Coronary flow reserve [ Time Frame: Within the first 3 days postoperatively ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 20, 2009)		 Diabetic autonomic neuropathy [ Time Frame: Within the first 3 days postoperatively ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Coronary Blood Flow Regulation During General Anesthesia
Official Title Cardiac Sympathetic Innervation and Coronary Blood Flow Regulation During General Anesthesia
Brief Summary

The central hypothesis in the present project is that general anesthesia may alter autonomic control such that perioperative coronary blood flow (CBF) is significantly disturbed.

These disturbances in coronary blood flow may contribute to the development of myocardial ischemia in the perioperative period. Furthermore, patients with an intrinsically altered autonomic sympathetic innervation, like diabetics, are even more prone to develop perioperative disturbances in coronary blood flow.

Here the researchers will investigate what the direct effects are of general and locoregional anesthesia on the CBF. Furthermore, the researchers aim to evaluate whether diabetic subjects show more disturbed CBF responses to anesthesia as compared to non-diabetics.
Detailed Description

In response to intraoperative stress, increased autonomic sympathetic activity may alter myocardial oxygen demand. Under normal physiological circumstances, sympathetic stimulation increases myocardial blood flow via adrenergic coronary vasodilation. However, coronary vessels contain both α- and β-adrenoreceptors, and if the coronary circulation is impaired due to cardiovascular disease, unopposed adrenergic coronary vasoconstriction may contribute to ischemia. Anesthetics reduce both coronary blood flow (CBF) regulation and the sympathetic autonomic nervous activity. However, it is unclear whether anesthetic-related reductions in CBF are a result of inhibited autonomic sympathetic innervation. Data regarding alterations in myocardial blood flow in response to sympathetic stimulation during anesthesia provide conflicting results. Moffitt and Sethna showed in patients undergoing cardiac surgery that CBF decreased during sternotomy-induced sympathetic stimulation, whereas Kirno et al. showed an increase in coronary blood flow after sternotomy. To our best knowledge, coronary vascular responses to sympathetic stimulation in anesthetized healthy humans are lacking because of absence of reliable non-invasive measurement of myocardial blood flow. The introduction of non-invasive contrast-echocardiographic techniques that allow evaluation of regional myocardial blood flow enable evaluation of the relation between autonomic control and CBF during anesthesia.

Cardiac complications like myocardial ischemia remain one of the main causes of perioperative morbidity and mortality. Interestingly, the presence of cardiovascular autonomic neuropathy (CAN) strongly predicts abnormalities in myocardial perfusion and impaired coronary vasodilator responses to stress. This implies that symptoms of CAN, like resting tachycardia, orthostasis and alterations in heart rate variability may predict the degree of impairment of CBF regulation. Indeed, autonomic neuropathy as determined by heart rate variability predicted mortality in patients with coronary artery disease undergoing non-cardiac surgery, but the contribution of impaired coronary vasodilatory responses to these results has not been established. Clarification of the relation between autonomic control and CBF during anesthesia may not only contribute to our insight in pro-ischemic processes in the heart, but may lead to changes in preoperative assessment of patients at risk for perioperative ischemia, thereby reducing perioperative complications.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Frozen plasma will be retained
Sampling Method Probability Sample
Study Population The study population consists patients scheduled for surgery and general anesthesia. Patients will be recruited from the preoperative screening clinic in the four, aforementioned, groups of patients.
Condition
  • Myocardial Ischemia
  • Autonomic Neuropathy
  • Healthy
  • Diabetes
Intervention Not Provided
Study Groups/Cohorts
  • Healthy
    Healthy subjects scheduled for general anesthesia
  • Healthy with thoracic epidural anelgesia
    Healthy subjects scheduled for general anesthesia and thoracic epidural analgesia
  • Diabetes
    Subjects with diabetes scheduled for general anesthesia
  • Diabetes with autonomic neuropathy
    Subjects with diabetes and cardiovascular autonomic neuropathy scheduled for general anesthesia
Publications * Bulte CS, van den Brom CE, Loer SA, Boer C, Bouwman RA. Myocardial blood flow under general anaesthesia with sevoflurane in type 2 diabetic patients: a pilot study. Cardiovasc Diabetol. 2014 Mar 23;13:62. doi: 10.1186/1475-2840-13-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2015)		 45
Original Estimated Enrollment
 (submitted: March 20, 2009)		 52
Actual Study Completion Date October 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • male
  • age between 18-75 years
  • scheduled for non-cardiac intermediate or high risk surgery
  • for patient group 2: indication for thoracic epidural anesthesia

Exclusion Criteria:

  • neurosurgery
  • known/documented cardiac disease
  • (untreated) hypertension
  • abnormal ECG or echocardiogram
  • peripheral vascular disease
  • renal disease requiring hemo- or peritoneal dialysis
  • inability to perform transthoracic echocardiography
  • medication interfering with presynaptic catecholamine uptake
  • for patient group 2: contra-indication for thoracic epidural anesthesia (bleeding diathesis, infection at the puncture site, patient refusal, severe stenotic valvular disease)
  • previous allergic reaction to echocardiographic contrast agents
  • contraindications for the use of echocardiographic contrast agents
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00866801
Other Study ID Numbers ANES 2008-12
2008 T003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party C.S.E. Bulte, Amsterdam UMC, location VUmc
Original Responsible Party C.S.E. Bulte, VU University Medical Center
Current Study Sponsor Amsterdam UMC, location VUmc
Original Study Sponsor Same as current
Collaborators Netherlands Heart Foundation
Investigators
Principal Investigator: Carolien SE Bulte, MD Amsterdam UMC, location VUmc
Principal Investigator: R. A. Bouwman, MD, PhD Amsterdam UMC, location VUmc
Study Chair: C. Boer, PhD Amsterdam UMC, location VUmc
Study Director: S. A. Loer, MD, PhD, MSC Amsterdam UMC, location VUmc
Study Chair: O. Kamp, MD, PhD Amsterdam UMC, location VUmc
Study Chair: M. Diamant, MD, PhD Amsterdam UMC, location VUmc
PRS Account Amsterdam UMC, location VUmc
Verification Date October 2015