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A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

ConditionHypotension Drug-Induced
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDalian Municipal Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-III, age 18-80 years

Elective abdominal surgery

Signed informed consent

Disqualifiers

ASA≥IV

Preoperative unstable blood hemodynamics

Allergy to ephedrine, phenylephrine or norepinephrine

Decrease in MAP <20%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ephedrine-P

    Drug

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

  • Phenylephrine-P

    Drug

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

  • Norepinephrine-P

    Drug

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

  • Ephedrine-S

    Drug

    after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

  • Phenylephrine-S

    Drug

    after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

  • Norepinephrine-S

    Drug

    after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Treatment groups

180 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Ephedrine-PropofolExperimental treatment 1 intervention
Group B: Phenylephrine-propofolExperimental treatment 1 intervention
Group C: Norepinephrine-propofolExperimental treatment 1 intervention
Group D: Ephedrine-sevofluraneActive comparator 1 intervention
Group E: Phenylephrine-sevofluraneActive comparator 1 intervention
Group F: Norepinephrine-sevofluraneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Continual changes in Cerebral Oxygen Saturation

This outcome is measured by near-infrared spectroscopy

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 outcomes

1

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

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
2

Continual changes in heart rate (HR)

This outcome is measured by LiDCO rapidV3 monitoring system

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
3

Continual changes in stroke volume (SV)

This outcome is measured by LiDCO rapidV3 monitoring system

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
4

Continual changes in cardiac output (CO)

This outcome is measured by LiDCO rapidV3 monitoring system

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dalian Municipal Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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