A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ephedrine-P, Phenylephrine-P, Norepinephrine-P, Ephedrine-S.
- Who it may be relevant to
- Registry conditions: Hypotension Drug-Induced. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Vasopressor on Cerebral Oxygenation During General Anesthesia in Abdominal Surgery
Overview
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.
Interventions
- Drug Ephedrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol - Drug Phenylephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol - Drug Norepinephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol - Drug Ephedrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane - Drug Phenylephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane - Drug Norepinephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Primary outcome measures
- Continual changes in Cerebral Oxygen Saturation [Time frame: 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 outcome measures (5)
- Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) [Time frame: 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]
- Continual changes in heart rate (HR) [Time frame: 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]
- Continual changes in stroke volume (SV) [Time frame: 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]
- Continual changes in cardiac output (CO) [Time frame: 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]
- Continual changes in systemic vascular resistance (SVR) [Time frame: 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Dalian Municipal Central Hospital — Dalian
Identifiers
NCT: NCT06334549 · LSKY2023-107-01