NCT00866801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

4.8 years

First QC Date

March 20, 2009

Last Update Submit

October 12, 2015

Conditions

Myocardial IschemiaAutonomic NeuropathyHealthyDiabetes

Keywords

coronary blood flowcoronary flow reservecardiac sympathetic innervationgeneral anesthesiathoracic epiduralautonomic dysfunctionautonomic neuropathy

Outcome Measures

Primary Outcomes (1)

  • Coronary flow reserve

    Within the first 3 days postoperatively

Secondary Outcomes (1)

  • Diabetic autonomic neuropathy

    Within the first 3 days postoperatively

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1007 MB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24656118DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen plasma will be retained

MeSH Terms

Conditions

Myocardial IschemiaDiabetes MellitusPrimary Dysautonomias

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutonomic Nervous System DiseasesNervous System Diseases

Study Officials

  • Carolien SE Bulte, MD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • R. A. Bouwman, MD, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • C. Boer, PhD

    Amsterdam UMC, location VUmc

    STUDY CHAIR

  • S. A. Loer, MD, PhD, MSC

    Amsterdam UMC, location VUmc

    STUDY DIRECTOR

  • O. Kamp, MD, PhD

    Amsterdam UMC, location VUmc

    STUDY CHAIR

  • M. Diamant, MD, PhD

    Amsterdam UMC, location VUmc

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 20, 2009

First Posted

March 23, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

NL(1)