AnxietyNCT03603873
Preoperative Anxiety Level, Premedications and General Anaesthetic Proceedings
An observational study of Anxiety and Premedication, run by CHU de Reims at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Premedication, General Anaesthetic
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2017to 24 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with scheduled or urgent surgical procedure
Who may be able to join
- 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
Who cannot join
- ASA 4 level
- Patient refusal
- pregnancy
- Rapid Sequence Induction (ISR)
- General Anaesthetic induction procedure using another drug than propofol (thiopental - etomidate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Premedication, General Anaesthetic
- Keywords
- Anxiety, Premedication, general anaesthetic
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety level
this outcome will be interpreted according to the preoperative anxiety level (APAIS score)
Measured: Day 0
Premeds
this outcome will be interpreted according to the use or not of premeds
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start3 Mar 2017
- Primary completion24 May 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603873
- Sponsor's protocol ID
- PZ17011
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings
- ClinicalTrials.gov ID
- NCT03603873
- Acronym / sponsor ID
- PZ17011
- Conditions
- Anxiety, Premedication, General Anaesthetic
- Keywords
- Anxiety, Premedication, general anaesthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with scheduled or urgent surgical procedure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- ASA 4 level
- Patient refusal
- pregnancy
- Rapid Sequence Induction (ISR)
- General Anaesthetic induction procedure using another drug than propofol (thiopental - etomidate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative anxiety level
Time frame: Day 0
this outcome will be interpreted according to the preoperative anxiety level (APAIS score)
Premeds
Time frame: Day 0
this outcome will be interpreted according to the use or not of premeds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Premedication, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety level (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.