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Preoperative Anxiety Level, Premedications and General Anaesthetic Proceedings

Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03603873
Enrollment
1200
Registered
2018-07-27
Start date
2017-03-03
Completion date
2017-05-24
Last updated
2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, General Anaesthetic, Premedication

Keywords

Anxiety, Premedication, general anaesthetic

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.

Detailed 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.

Interventions

None listed

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Preoperative anxiety levelDay 0this outcome will be interpreted according to the preoperative anxiety level (APAIS score)
PremedsDay 0this outcome will be interpreted according to the use or not of premeds

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026