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NCT Number: NCT06334549

A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

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.

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Key information

Conditions

Hypotension Drug-Induced Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dalian Municipal Central Hospital

Dalian, Liaoning, 116033, China

Location status: Recruiting

Location contact

Liping Han, M.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine-P

Drug

after induction of anesthesia, use total intravenous anesthesia maintained with propofol

Other names: vasopressor

Phenylephrine-P

Drug

after induction of anesthesia, use total intravenous anesthesia maintained with propofol

Other names: vasopressor

Norepinephrine-P

Drug

after induction of anesthesia, use total intravenous anesthesia maintained with propofol

Other names: vasopressor

Ephedrine-S

Drug

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Other names: vasopressor

Phenylephrine-S

Drug

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Other names: vasopressor

Norepinephrine-S

Drug

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Other names: vasopressor

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Liping Han, MD, MSc

CONTACT

[email protected]

86-411-84412001

Sponsors and collaborators

Lead sponsor

Dalian Municipal Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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