NCT01796210

Brief Summary

The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

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

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

February 18, 2013

Last Update Submit

June 6, 2013

Conditions

Anesthesia

Keywords

Analgesia/nociception indexBispectral indexPropofolRemifentanilSuspension laryngoscopyEndoscopyEar-nose-throat

Outcome Measures

Primary Outcomes (1)

  • Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes

    Before induction of anesthesia, 1 min after beginning of procedure, at steady-state anesthesia during procedure (an expected average of 10 min) and at arousal from general anesthesia in the end of procedure (an expected average of 20 min)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients underoing suspension laryngoscopy performed on general anesthesia

You may qualify if:

  • Age 18-75 years
  • Suspension laryngoscopy for diagnostic or therapeutic purposes
  • Total intravenous anesthesia using propofol and remifentanil

You may not qualify if:

  • age \<18 yrs or \>75 yrs
  • arrythmia
  • administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
  • psychiatric diseases
  • autonomic nervous system disorders (epilepsy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Édouard Herriot, HCL

Lyon, Rhône, 69003, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuel Boselli, MD, PhD

    Hôpital Édouard Herriot, HCL

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 21, 2013

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

FR(1)