Effects of Vasopressor on Cerebral Oxygenation During General Anesthesia in Abdominal Surgery
Overview
- Phase
- Phase 4
- Intervention
- Ephedrine-P
- Conditions
- Hypotension Drug-Induced
- Sponsor
- Dalian Municipal Central Hospital
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Continual changes in Cerebral Oxygen Saturation
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Liping Han
Professor & Vice Director
Dalian Municipal Central Hospital
Eligibility Criteria
Inclusion Criteria
- •ASA I-III, age 18-80 years
- •Elective abdominal surgery
- •Signed informed consent
Exclusion Criteria
- •Preoperative unstable blood hemodynamics
- •Allergy to ephedrine, phenylephrine or norepinephrine
- •Decrease in MAP \<20%
- •Severe cardiovascular disorder
Arms & Interventions
Ephedrine-Propofol
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.
Intervention: Ephedrine-P
Phenylephrine-propofol
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.
Intervention: Phenylephrine-P
Norepinephrine-propofol
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.
Intervention: Norepinephrine-P
Ephedrine-sevoflurane
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.
Intervention: Ephedrine-S
Phenylephrine-sevoflurane
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.
Intervention: Phenylephrine-S
Norepinephrine-sevoflurane
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.
Intervention: Norepinephrine-S
Outcomes
Primary Outcomes
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
This outcome is measured by near-infrared spectroscopy
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)