A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

Dalian Municipal Central Hospital

Status and phase: Enrolling; Phase 4

Conditions: Hypotension Drug-Induced

Treatments: Drug: Phenylephrine-S; Drug: Norepinephrine-S; Drug: Ephedrine-P; Drug: Norepinephrine-P; Drug: Phenylephrine-P; Drug: Ephedrine-S

Study type: Interventional

Funder types: Other

Identifiers

NCT06334549

LSKY2023-107-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 6 patient groups

Ephedrine-Propofol

Experimental group

Description:

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.

Treatment:

Drug: Ephedrine-P

Phenylephrine-propofol

Experimental group

Description:

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.

Treatment:

Drug: Phenylephrine-P

Norepinephrine-propofol

Experimental group

Description:

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.

Treatment:

Drug: Norepinephrine-P

Ephedrine-sevoflurane

Active Comparator group

Description:

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.

Treatment:

Drug: Ephedrine-S

Phenylephrine-sevoflurane

Active Comparator group

Description:

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.

Treatment:

Drug: Phenylephrine-S

Norepinephrine-sevoflurane

Active Comparator group

Description:

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.

Treatment:

Drug: Norepinephrine-S