Preoperative Anxiety Level, Premedications and General Anaesthetic Proceedings

Anxiety Clinical Trial

Official title:

Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603873
• Other study ID #: PZ17011
• Status: Completed
• Start date: March 3, 2017
• Est. completion date: May 24, 2017

Study information

• Verified date: July 2018
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study will be carried out in solely at the institute of CHU de Reims, France (Reims Teaching Hospital) from March 2017 to May 2017. Selected patients will be over the age of 18, among those receiving general anaesthesia for surgery. Demographic data and medical history will be collected after written consent. Before the anaesthetic procedure, an APAIS questionnaire (Anxiety evaluation form) will be filled out by each patient.

The medical, anaesthetic and surgical care will not be changed. In the operating room, we will proceed with anaesthetic induction following a medical protocol according to the practice of our hospital (TCI Target Controlled Infusion or manual induction): the propofol infusion or injection is started with an initial effect-site concentration or dose and increased step by step until patients present the clinical en points defined as LOC (loss of consciousness, i.e. no response to a verbal command).

The effect-site concentration of propofol, induction time required for a loss of consciousness (LOC), and preoperative incidents will be recorded by an anaesthetist student nurse and will be recorded in a data book.

After surgery, we will record any secondary effect attributable to premedication.

The day after surgery, patients will be assessed with the EVAN-G questionnaire. Statistical analysis will be done in sub-groups with variance analysis. We will also do multivariate regression analysis according to the type of premedication, demographic data, preoperative variable and preoperative anxiety level. If the number of included patients allows it, we will do propensity score matching for premedication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: May 24, 2017
• Est. primary completion date: May 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• ASA 4 level

• Patient refusal

• pregnancy

• Rapid Sequence Induction (ISR)

• General Anaesthetic induction procedure using another drug than propofol (thiopental - etomidate)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• General Anaesthetic
• Premedication

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative anxiety level	this outcome will be interpreted according to the preoperative anxiety level (APAIS score)	Day 0
Primary	Premeds	this outcome will be interpreted according to the use or not of premeds	Day 0