NCT06334549

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2025

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

March 8, 2024

Last Update Submit

November 4, 2024

Conditions

Hypotension Drug-Induced

Keywords

Abdominal surgeryephedrinephenylephrinenorepinephrinecerebral oxygen saturationMAPCOGeneral anesthesiaPropofolSevofluraneHypotension Drug-induced

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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 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 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 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 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

Study Arms (6)

Ephedrine-Propofol

EXPERIMENTAL

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.

Drug: Ephedrine-P

Phenylephrine-propofol

EXPERIMENTAL

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.

Drug: Phenylephrine-P

Norepinephrine-propofol

EXPERIMENTAL

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.

Drug: Norepinephrine-P

Ephedrine-sevoflurane

ACTIVE COMPARATOR

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.

Drug: Ephedrine-S

Phenylephrine-sevoflurane

ACTIVE COMPARATOR

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.

Drug: Phenylephrine-S

Norepinephrine-sevoflurane

ACTIVE COMPARATOR

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.

Drug: Norepinephrine-S

Interventions

Ephedrine-PDRUG

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

Also known as: vasopressor
Ephedrine-Propofol
Phenylephrine-PDRUG

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

Also known as: vasopressor
Phenylephrine-propofol
Norepinephrine-PDRUG

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

Also known as: vasopressor
Norepinephrine-propofol
Ephedrine-SDRUG

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Also known as: vasopressor
Ephedrine-sevoflurane
Phenylephrine-SDRUG

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Also known as: vasopressor
Phenylephrine-sevoflurane
Norepinephrine-SDRUG

after induction of anesthesia, use inhalation anesthesia maintained with sevoflurane

Also known as: vasopressor
Norepinephrine-sevoflurane

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III, age 18-80 years
  • Elective abdominal surgery
  • Signed informed consent

You may not qualify if:

  • ASA≥IV
  • Preoperative unstable blood hemodynamics
  • Allergy to ephedrine, phenylephrine or norepinephrine
  • Decrease in MAP \<20%
  • Severe cardiovascular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalian Municipal Central Hospital

Dalian, Liaoning, 116033, China

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Vasoconstrictor Agentsephedrine phosphate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Hong Fang, MD

    Dalian Municipal Central Hospital

    STUDY CHAIR

Central Study Contacts

Liping Han, MD, MSc

CONTACT

86-411-84412001han651310@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Vice Director

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 28, 2024

Study Start

March 5, 2024

Primary Completion

December 5, 2025

Study Completion

December 5, 2025

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)