NCT03603873

Brief Summary

Although it seems obvious that the high level of preoperative anxiety may affect intraoperative anaesthetic requirements and recovery adversely, there are several contradictory studies about this subject. Furthermore, the effects of anxiolytic premedication are actually disputed: sedative premedication is widely administered but little clinical evidence supports its use. We want to evaluate the effects of pre-procedure anxiety for propofol needs in patients receiving general anaesthetic procedure. We also want to know if premedication is useful according to the preoperative anxiety level, in order to determine if a sub-group of patients benefit from it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

July 19, 2018

Last Update Submit

July 19, 2018

Conditions

AnxietyPremedicationGeneral Anaesthetic

Keywords

AnxietyPremedicationgeneral anaesthetic

Outcome Measures

Primary Outcomes (2)

  • Preoperative anxiety level

    this outcome will be interpreted according to the preoperative anxiety level (APAIS score)

    Day 0

  • Premeds

    this outcome will be interpreted according to the use or not of premeds

    Day 0

Study Arms (1)

Patients

Eligibility Criteria

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

Adult patients with scheduled or urgent surgical procedure

You may qualify if:

  • age \> 18 years old
  • surgery with general anaesthetic, programmed, in emergency or ambulatory
  • Cognitive level adequate to submit APAIS - EVANG form
  • General anaesthetic induction procedure using propofol

You may not qualify if:

  • ASA 4 level
  • Patient refusal
  • pregnancy
  • Rapid Sequence Induction (ISR)
  • General Anaesthetic induction procedure using another drug than propofol (thiopental - etomidate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 27, 2018

Study Start

March 3, 2017

Primary Completion

May 24, 2017

Study Completion

May 24, 2017

Last Updated

July 27, 2018

Record last verified: 2018-07

Locations

FR(1)