A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

November 4, 2024 updated by: Liping Han, Dalian Municipal Central Hospital

Effects of Vasopressor on Cerebral Oxygenation During General Anesthesia in Abdominal Surgery

The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was a single-center, randomized, double-blinded, controlled trial. First, the effects of E, P, or N on cerebral oxygen saturation(rScO2) under general anesthesia in abdominal surgery were studied. Patients with abdominal surgery were evaluated using near-infrared spectroscopy. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured with LiDCO rapidV3 monitoring system. To investigate the individualized therapeutic options & specific mechanisms of the three vasopressors on rScO2 and CO.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Recruiting
        • Dalian Municipal Central Hospital
        • Contact:
          • Liping Han, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I-III, age 18-80 years
  • Elective abdominal surgery
  • Signed informed consent

Exclusion Criteria:

  • ASA≥IV
  • Preoperative unstable blood hemodynamics
  • Allergy to ephedrine, phenylephrine or norepinephrine
  • Decrease in MAP <20%
  • Severe cardiovascular disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ephedrine-Propofol
receive ephedrine 0.15mg/kg (configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
Drug: Ephedrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Other Names:
  • vasopressor
Experimental: Phenylephrine-propofol
receive phenylephrine 2.5ug/kg(configured concentration 100ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
Drug: Phenylephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Other Names:
  • vasopressor
Experimental: Norepinephrine-propofol
receive norepinephrine 0.2ug/kg(configured concentration 8μg/ml) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
Drug: Norepinephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Other Names:
  • vasopressor
Active Comparator: Ephedrine-sevoflurane
receive Ephedrine 0.15mg/kg(configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
Drug: Ephedrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Other Names:
  • vasopressor
Active Comparator: Phenylephrine-sevoflurane
receive phenylephrine 2.5ug/kg(configured concentration 80ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
Drug: Phenylephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Other Names:
  • vasopressor
Active Comparator: Norepinephrine-sevoflurane
receive norepinephrine 0.2ug/kg(configured concentration 8ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
Drug: Norepinephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Other Names:
  • vasopressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continual changes in Cerebral Oxygen Saturation
Time Frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by near-infrared spectroscopy
10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)
Time Frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by LiDCO rapidV3 monitoring system
10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in heart rate (HR)
Time Frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by LiDCO rapidV3 monitoring system
10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in stroke volume (SV)
Time Frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by LiDCO rapidV3 monitoring system
10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in cardiac output (CO)
Time Frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by LiDCO rapidV3 monitoring system
10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
Continual changes in systemic vascular resistance (SVR)
Time Frame: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by LiDCO rapidV3 monitoring system
10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalian Municipal Central Hospital

Investigators

  • Study Chair: Hong Fang, MD, Dalian Municipal Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

December 5, 2025

Study Completion (Estimated)

December 5, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSKY2023-107-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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