Clinical trial

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

Name

LSKY2023-107-01

Description

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.

Trial arms

Trial start

2024-03-05

Estimated PCD

2024-12-05

Trial end

2024-12-05

Status

Recruiting

Phase

Early phase I

Treatment

Ephedrine-P

after induction of anesthesia, use total intravenous anesthesia maintained with propofol

Arms:

Ephedrine-Propofol

Other names:

vasopressor

Phenylephrine-P

after induction of anesthesia, use total intravenous anesthesia maintained with propofol

Arms:

Phenylephrine-propofol

Other names:

vasopressor

Norepinephrine-P

after induction of anesthesia, use total intravenous anesthesia maintained with propofol

Arms:

Norepinephrine-propofol

Other names:

vasopressor

Ephedrine-S

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Arms:

Ephedrine-sevoflurane

Other names:

vasopressor

Phenylephrine-S

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Arms:

Phenylephrine-sevoflurane

Other names:

vasopressor

Norepinephrine-S

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Arms:

Norepinephrine-sevoflurane

Other names:

vasopressor

Size

180

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

Updated at

2024-03-28

1 organization

6 products

1 indication

Organization

Dalian Municipal Central Hospital

Product

Ephedrine-P

Indication

Drug-Induced Hypotension

Product