- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03603873
Preoperative Anxiety Level, Premedications and General Anaesthetic Proceedings
Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Reims, France
- Damien JOLLY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preoperative anxiety level
Time Frame: Day 0
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this outcome will be interpreted according to the preoperative anxiety level (APAIS score)
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Day 0
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Premeds
Time Frame: Day 0
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this outcome will be interpreted according to the use or not of premeds
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Day 0
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PZ17011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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