Anxiety Clinical Trial
Official title:
Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings
NCT number | NCT03603873 |
Other study ID # | PZ17011 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 3, 2017 |
Est. completion date | May 24, 2017 |
Verified date | July 2018 |
Source | CHU de Reims |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
France | Damien JOLLY | Reims |
Lead Sponsor | Collaborator |
---|---|
CHU de Reims |
France,
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 |
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