A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

Phase 4

Recruiting

• Conditions: Hypotension Drug-Induced
• Interventions: Drug: Ephedrine-P; Drug: Ephedrine-S; Drug: Norepinephrine-S; Drug: Phenylephrine-P; Drug: Norepinephrine-P; Drug: Phenylephrine-S

• Registration Number: NCT06334549
• Lead Sponsor: Dalian Municipal Central Hospital

Brief Summary

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

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 Timeline

• Study Start: 2024-03-05
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-03-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-12-05
• Study Completion: 2025-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ephedrine-Propofol	Ephedrine-P	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.
Ephedrine-sevoflurane	Ephedrine-S	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.
Norepinephrine-sevoflurane	Norepinephrine-S	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.
Phenylephrine-propofol	Phenylephrine-P	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.
Norepinephrine-propofol	Norepinephrine-P	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.
Phenylephrine-sevoflurane	Phenylephrine-S	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.

Primary Outcome Measures

Name	Time	Method
Continual changes in Cerebral Oxygen Saturation	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 Outcome Measures

Name	Time	Method
Continual changes in heart rate (HR)	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
Continual changes in cardiac output (CO)	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
Continual changes in stroke volume (SV)	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
Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)	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
Continual changes in systemic vascular resistance (SVR)	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

Trial Locations

Locations (1)

Dalian Municipal Central Hospital; 🇨🇳 Dalian, Liaoning, China