NCT01594021

Brief Summary

Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

May 5, 2012

Last Update Submit

October 28, 2016

Conditions

Anesthesia

Keywords

propofolanesthesia, inductionhypotensioncardiac output

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    mean arterial pressure less than 70% of the baseline measurement

    30 minutes

Secondary Outcomes (6)

  • hemodynamic effect of leg passive elevation test

    30 minutes

  • hemodynamic effect of volume loading

    30 minutes

  • heart rate monitoring

    30 minutes

  • propofol dose when bispectral index is 50

    30 minutes

  • propofol site effect concentration when bispectral index is 50

    30 minutes

  • +1 more secondary outcomes

Study Arms (2)

High pre-emptive volume loading

EXPERIMENTAL
Drug: Gelatin 500 mL

Low pre-emptive volume loading

ACTIVE COMPARATOR
Drug: Gelatin 50 mL

Interventions

Gelatin 500 mLDRUG

intravenous administration

High pre-emptive volume loading
Gelatin 50 mLDRUG

intravenous administration

Low pre-emptive volume loading

Eligibility Criteria

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

You may qualify if:

  • Adult patients undergoing elective surgery.

You may not qualify if:

  • Difficult peripheral venous access
  • Allergy to gelatin
  • Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease
  • Morbid obesity, low BMI,
  • hypovolemia,
  • Raynaud syndrome or scleroderma,
  • Contra-indication to propofol, remifentanil or to the use of Bispectral Index,
  • Hematocrit \< 20%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Hypotension

Interventions

Gelatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Morgan Le Guen

    Hopital Foch

    PRINCIPAL INVESTIGATOR

  • Marc Fischler

    Hopital Foch

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2012

First Posted

May 8, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(1)