NCT01759160

Brief Summary

To compare the hemodynamic changes during anesthesia induction between Marsh and Schnider plasma TCI models. We put forward a hypothesis that, if one TCI model is associated with much more prominent vasodilation effect or cardiac depression, a more sharp decrease in mean arterial pressure, systemic vascular resistance , central venous return or stroke volume would be observed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 22, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1 month

First QC Date

December 20, 2012

Results QC Date

January 16, 2013

Last Update Submit

March 21, 2013

Conditions

Healthy

Keywords

Target control infusionpropofolcardiac depressioninduction of anesthesiahemodynamics

Outcome Measures

Primary Outcomes (1)

  • SVI (Stroke Volume Index) Value Change From Baseline Level at the End of the First 25 Minutes.

    After propofol infusion started, according to sedation level, TCI targets were gradually titrated to reach a state of equilibrium at the end of the first 25 minutes. SVI were continuously monitored, at the end of the first 25 minutes, value change from baseline level were calculated.

    The end of the first 25 minutes after propofol infusion

Secondary Outcomes (2)

  • NI (Narcotrend Index) Reduction

    25 minutes after propofol infusion

  • CVP (Central Venous Pressure)

    25 minutes after induction

Study Arms (2)

Marsh

ACTIVE COMPARATOR

Marsh Plasma TCI with high initial target

Procedure: Marsh Plasma TCI with high initial target

Schnider

ACTIVE COMPARATOR

Schnider Plasma TCI with high initial target

Procedure: Schnider Plasma TCI with high initial target

Interventions

Marsh Plasma TCI with high initial targetPROCEDURE

plasma target-controlled infusion in Marsh model(n=30) with an initial target concentration of 4 μg/ml. Target was then reset and gradually titrated to a sedation level with narcotrend index below 64.

Also known as: Plasma target-controlled infusion in Marsh model
Marsh
Schnider Plasma TCI with high initial targetPROCEDURE

plasma target-controlled infusion in Schnider model(n=30) with an initial target concentration of 4 μg/ml. Target was then reset and gradually titrated to a sedation level with narcotrend index below 64.

Also known as: Plasma target-controlled infusion in Schnider model
Schnider

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between the ages of 18 years and 70 years
  • ASA physical status I and II
  • surgical procedures requiring general anesthesia with continuous CVP and arterial pressure monitoring.

You may not qualify if:

  • Patients younger than 16 y or older than 65 y
  • Body Mass Index (BMI) \<18 or \>30
  • emergency surgery
  • allergy to any of the drugs used
  • inability to communicate effectively
  • severe cardiovascular dysfunction
  • patient refusal and patients on long-term opioids or sedative medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Yang XY, Zhou ZB, Yang L, Zhou X, Niu LJ, Feng X. Hemodynamic responses during induction: comparison of Marsh and Schnider pharmacokinetic models. Int J Clin Pharmacol Ther. 2015 Jan;53(1):32-40. doi: 10.5414/CP202141.

    PMID: 25500489DERIVED

Results Point of Contact

Title
Dr. Xia Feng
Organization
First Affiliated Hospital of Sun Yat-sen University
fengxiar@yahoo.cn
008613688877856

Study Officials

  • Xia Feng, M.D.

    The First Affiliaed Hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

December 20, 2012

First Posted

January 3, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 29, 2013

Results First Posted

March 22, 2013

Record last verified: 2013-03

Locations

CN(1)