Hypotension Drug-Induced
Conditions
Keywords
Abdominal surgery, ephedrine, phenylephrine, norepinephrine, cerebral oxygen saturation, MAP, CO, General anesthesia, Propofol, Sevoflurane, Hypotension Drug-induced
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.
Interventions
DRUGEphedrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
DRUGPhenylephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
DRUGNorepinephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
DRUGEphedrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
DRUGPhenylephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
DRUGNorepinephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
Sponsors
Dalian Municipal Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLiping Han, MD, MSc
Outcome results
None listed