A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

Hypotension Drug-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334549
• Other study ID #: LSKY2023-107-01
• Status: Recruiting
• Phase: Phase 4
• Start date: March 5, 2024
• Est. completion date: December 5, 2024

Study information

• Verified date: March 2024
• Source: Dalian Municipal Central Hospital
• Contact: Liping Han, MD, MSc
• Phone: 86-411-84412001
• Email: han651310[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 5, 2024
• Est. primary completion date: December 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension Drug-Induced

Intervention

Drug:
• Ephedrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
• Phenylephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
• Norepinephrine-P
after induction of anesthesia, use total intravenous anesthesia maintained with propofol
• Ephedrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
• Phenylephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane
• Norepinephrine-S
after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Locations

Country	Name	City	State
China	Dalian Municipal Central Hospital	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Dalian Municipal Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continual changes in Cerebral Oxygen Saturation	This outcome is measured by near-infrared spectroscopy	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	Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)	This outcome is measured by LiDCO rapidV3 monitoring system	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	Continual changes in heart rate (HR)	This outcome is measured by LiDCO rapidV3 monitoring system	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	Continual changes in stroke volume (SV)	This outcome is measured by LiDCO rapidV3 monitoring system	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	Continual changes in cardiac output (CO)	This outcome is measured by LiDCO rapidV3 monitoring system	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	Continual changes in systemic vascular resistance (SVR)	This outcome is measured by LiDCO rapidV3 monitoring system	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