A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

NCT ID: NCT06334549

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-12-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypotension Drug-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Ephedrine-P

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Phenylephrine-P

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Norepinephrine-P

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Ephedrine-S

Intervention Type DRUG

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

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.

Group Type ACTIVE_COMPARATOR

Phenylephrine-S

Intervention Type DRUG

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

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.

Group Type ACTIVE_COMPARATOR

Norepinephrine-S

Intervention Type DRUG

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Interventions

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Ephedrine-P

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

Intervention Type DRUG

Phenylephrine-P

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

Intervention Type DRUG

Norepinephrine-P

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

Intervention Type DRUG

Ephedrine-S

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Intervention Type DRUG

Phenylephrine-S

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Intervention Type DRUG

Norepinephrine-S

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Intervention Type DRUG

Other Intervention Names

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vasopressor vasopressor vasopressor vasopressor vasopressor vasopressor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalian Municipal Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liping Han

Professor & Vice Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Fang, MD

Role: STUDY_CHAIR

Dalian Municipal Central Hospital

Locations

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Dalian Municipal Central Hospital

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liping Han, MD, MSc

Role: CONTACT

86-411-84412001

Facility Contacts

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Liping Han, M.D.

Role: primary

Other Identifiers

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LSKY2023-107-01

Identifier Type: -

Identifier Source: org_study_id

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