The Effect of Blood Pressure on Cerebral Blood Flow During Propofol Anesthesia

NCT03309917 | Completed DMC

• 1 other identifier: H-17021598-61256
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia often reduces blood pressure whereby blood flow to the brain and other vital organs may become insufficient. Thus, medicine is often administered to maintain blood pressure but it is unclear at what level blood pressure should be aimed at during anesthesia. Thirty patients undergoing major abdominal surgery will be included. The study will start one hour after the start of surgery and lasts for approximately half an hour. The purpose of the study is to evaluate whether blood flow to the brain can be increased by maintaining blood pressure at a higher level than that used in clinical practice. In the study, MAP is adjusted to a high, moderate, and low level for a short time. The low level of blood pressure used in the study, corresponds to the level aimed at in clinical practice. The drug noradrenaline will be used to control blood pressure. Blood flow to the brain will be evaluated on the neck using ultrasound.

Conditions

Gastrointestinal Neoplasms; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Change in internal carotid artery blood flow when mean arterial pressure (MAP) is set to 80-85 and 60-65 mmHg

  Internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound when MAP is set to 80-85 and 60-65 mmHg for 5 min as part of the experiment during propofol anesthesia

  Values are recorded during 2 min at 2 time points; when MAP is set to 80-85 and 60-65 mmHg during propofol anesthesia as part of the study. The evaluations are separated by approximately 30 min

Secondary Outcomes (3)

• Change in internal carotid artery blood flow when MAP is set to 70-75 and 60-65 mmHg

  Values are recorded during 2 min at 2 time points; when MAP is set to 70-75 and 60-65 mmHg during propofol anesthesia as part of the study. The evaluations are separated by approximately 15 min

• Change in internal carotid artery blood flow when MAP is set to 80-85 and 70-75 mmHg

  Values are recorded during 2 min at 2 time points; when MAP is set to 80-85 and 70-75 mmHg during propofol anesthesia as part of the study. The evaluations are separated by approximately 15 min

• Comparison of the slope of linear regression of MAP and internal carotid artery blood flow for the evaluations when MAP is set to 80-85 and 70-75 mmHg and that of the evaluations when MAP is set to 70-75 and 60-65 mmHg

  Values are recorded during 2 min at 3 time points; when MAP is set to 80-85, 70-75, and 60-65 mmHg during propofol anesthesia as part of the study. The evaluations are separated by approximately 15 and 30 min

Study Arms (1)

Changes in mean arterial pressure

EXPERIMENTAL

The study is conducted from one hour after incision and lasts for approximately half an hour. Measurements are conducted at three levels of mean arterial pressure: * MAP set at 80-85 mmHg for 5 min. * MAP set at 70-75 mmHg for 5 min. * MAP set at 60-65 mmHg for 5 min. Blood pressure control is by infusion of noradrenaline. When the evaluations have been conducted blood pressure control is according to clinical practice. Measurements include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, frontal lobe and muscle oxygenation, depth of anesthesia, and arterial and central venous blood gas variables.

Other: MAP set at 80-85 mmHg for 5 min; Other: MAP set at 70-75 mmHg for 5 min; Other: MAP set at 60-65 mmHg for 5 min

Interventions

MAP set at 80-85 mmHg for 5 min OTHER

MAP is set at 80-85 mmHg for 5 min by infusion of noradrenaline.

Changes in mean arterial pressure

MAP set at 70-75 mmHg for 5 min OTHER

MAP is set at 70-75 mmHg for 5 min by infusion of noradrenaline.

Changes in mean arterial pressure

MAP set at 60-65 mmHg for 5 min OTHER

MAP is set at 60-65 mmHg for 5 min by infusion of noradrenaline.

Changes in mean arterial pressure

Eligibility Criteria

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

You may qualify if:

• Patient planned for Whipple's surgery or total pancreatic resection
• Age \> 18 years

You may not qualify if:

• No informed consent
• Alcohol intake ≥ 420 g / week
• Beard on the neck
• Visualization of the internal carotid artery not possible, e.g. due to high placement of the bifurcation
• Stenosis that obstructs ≥ 16% of the internal carotid artery
• Cardiac disease, including congestive heart failure (NYHA II-IV), myocardial infarction, valvular heart disease or atrial fibrillation
• Neurologic disease considered to affect cerebral blood flow, including dementia, epilepsy, and apoplexy
• Intake of moclobemide, isocarboxazid or tricyclic antidepressants

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Anaesthesia

Copenhagen, DK-2100, Denmark

Location

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MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Niels H Secher, MD, D.M.Sc.

  Department of Anesthesia, Rigshospitalet 2043, DK-2100 Copenhagen Ø, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 16, 2017
• Study Start: December 27, 2017
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)