Clinical trial NCT06334549: A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia
Official title: Effects of Vasopressor on Cerebral Oxygenation During General Anesthesia in Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypotension Drug-Induced
Keywords: Abdominal surgery
ephedrine
phenylephrine
norepinephrine
cerebral oxygen saturation
MAP
CO
General anesthesia
Propofol
Sevoflurane
Hypotension Drug-induced
Lead sponsor: Dalian Municipal Central Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continual changes in Cerebral Oxygen Saturation
timeFrame: 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
Secondary outcomes:
measure: Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)
timeFrame: 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
measure: Continual changes in heart rate (HR)
timeFrame: 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
measure: Continual changes in stroke volume (SV)
timeFrame: 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
measure: Continual changes in cardiac output (CO)
timeFrame: 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
measure: Continual changes in systemic vascular resistance (SVR)
timeFrame: 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
Other outcomes:
Locations:
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
Study officials:
affiliation: Dalian Municipal Central Hospital
name: Hong Fang, MD
role: STUDY_CHAIR
References: