A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

NCT06334549 — Phase 4, Recruiting, 180 participants, Dalian Municipal Central Hospital

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

Registry	NCT06334549
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	180 (Estimated)
Sponsor	Dalian Municipal Central Hospital (Other)
Conditions	Hypotension Drug-Induced
Interventions	Ephedrine-P, Phenylephrine-P, Norepinephrine-P, Ephedrine-S, Phenylephrine-S, Norepinephrine-S (Drug)
Dates	start 2024-03-05, primary completion 2025-12-05 (estimated), completion 2025-12-05 (estimated), first posted 2024-03-28, last updated 2024-11-06
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Ephedrine-Propofol	Experimental	Drug: 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.
Phenylephrine-propofol	Experimental	Drug: 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	Experimental	Drug: 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.
Ephedrine-sevoflurane	Active comparator	Drug: 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.
Phenylephrine-sevoflurane	Active comparator	Drug: 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.
Norepinephrine-sevoflurane	Active comparator	Drug: 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.

Ephedrine-P (Drug), also known as vasopressor: after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Phenylephrine-P (Drug), also known as vasopressor: after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Norepinephrine-P (Drug), also known as vasopressor: after induction of anesthesia, use total intravenous anesthesia maintained with propofol
Ephedrine-S (Drug), also known as vasopressor: after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Phenylephrine-S (Drug), also known as vasopressor: after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Norepinephrine-S (Drug), also known as vasopressor: after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

+Outcome measures

Primary outcomes

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 outcomes

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 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 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 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 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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
Dalian Municipal Central Hospital	Dalian, Liaoning	China	Recruiting

+Investigators

Hong Fang, MD, Study chair, Dalian Municipal Central Hospital

My Notes

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