The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery

NCT02531139 | Withdrawn DMC

• 1 other identifier: NDOlesen
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia reduces blood pressure and cerebral blood flow is normally considered to be maintained despite marked changes in blood pressure. Vascular surgical patients are often elderly, have high blood pressure and atherosclerosis and in these patients cerebral blood flow may decrease if blood pressure is reduced during anesthesia. The purpose of this study is to assess the effect of blood pressure for preservation of cerebral blood flow during anesthesia in vascular surgery. The hypothesis is that in vascular surgical patients, during anesthesia, cerebral blood flow is higher with blood pressure maintained at a higher level than that used in normal clinical practice.

Conditions

Anesthesia; Peripheral Arterial Diseases

Keywords

Cerebrovascular Circulation; Anesthesia; Blood pressure; Peripheral Arterial Diseases

Outcome Measures

Primary Outcomes (1)

• Middle cerebral artery blood velocity

  Middle cerebral artery blood velocity measured in \[cm/s\] assessed by transcranial Doppler. Changes in middle cerebral artery blood velocity reflects changes in cerebral blood flow.

  During surgery

Secondary Outcomes (5)

• Change in serum S100B as compared between subjects in the control- and intervention groups

  Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery

• Change in serum neuron-specific enolase as compared between subjects in the control- and intervention groups

  Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery

• Regional cerebral oxygenation as compared between subjects in the control- and intervention groups

  During surgery

• Cardiac output as compared between subjects in the control- and intervention groups

  During surgery

• Stroke volume as compared between subjects in the control- and intervention groups

  During surgery

Study Arms (2)

MAP maintained at 80 mmHg

EXPERIMENTAL

During anesthesia MAP is maintained at 80 - 90 mmHg MAP using continuous infusion of phenylephrine.

Other: MAP maintained at 80 mmHg

MAP maintained at 60 mmHg

ACTIVE COMPARATOR

During anesthesia MAP is maintained at minimum of 60 mmHg using continuous infusion of phenylephrine.

Other: MAP maintained at 60 mmHg

Interventions

MAP maintained at 80 mmHg OTHER

Intervention group, MAP is maintained at 80 - 90 mmHg during anesthesia using continuous infusion of phenylephrine.

MAP maintained at 80 mmHg

MAP maintained at 60 mmHg OTHER

Control group, MAP is maintained at minimum of 60 mmHg during anesthesia using continuous infusion of phenylephrine.

MAP maintained at 60 mmHg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing one of the following vascular surgical interventions in general anesthesia: Infra-inguinal bypass, femoro-femoral cross-over bypass or iliofemoral bypass surgery.
• Age \> 18 years. Informed consent

You may not qualify if:

• Use of monoamine oxidase inhibitors
• Allergy to phenylephrine
• Patients that cannot cooperate during examination
• Dementia defined as Mini-Mental State Examination \< 24
• Anesthesia within the last 30 days
• Alcohol consumption at or above 420 grams per week
• Lack of fluency in written and spoken Danish
• Severe hearing and vision impairment
• Neurological disease

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Anæstesi og Operationsklinikken 2043

Copenhagen Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Niels D. Olesen, MD

  Rigshospitalet, Anæstesi og Operationsklinikken 2043, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 24, 2015
• Study Start: March 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

DK (1)