Spinal AnesthesiaBAGNCT02529501
Spinal Versus General Anesthesia for Ambulatory Anesthesia
An observational study of Spinal Anesthesia and Short General Anesthesia, run by Nordic Pharma SAS at 1 site in France.
Trial summary
The purpose of this study is to describe, in real-life conditions, the factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthesia, Short General Anesthesia, Outpatient Surgery
- How many people
- 595 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Aug 2016
- 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: Patients scheduled for surgery under spinal anesthesia or short general anesthesia will be informed about the study and will be asked to participate.
Who may be able to join
- Adult patients undergoing an ambulatory surgery
- Patients for whom either a spinal anesthesia or a short general anesthesia is planned
- Patients accepting and able to complete a self-administered questionnaire in French language
- Informed patients who accept the computer processing of their medical data and their right of access and correction
Who cannot join
- Patients with contra-indications to elective ambulatory surgery
- Emergency surgeries
- Patient for which both spinal anesthesia and short general anesthesia coexist
- Patients with contra-indications to spinal anesthesia (due to surgical procedure site, comorbidities or patient's treatment)
- Patients participating or having participated in the previous month in a clinical trial in anaesthesiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Influencing the Choice of Anesthesia (Spinal Anesthesia or Short General Anesthesia) in Outpatient Surgery
The purpose of this study is to describe, in real-life conditions, the factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient surgery.
Read the detailed description
This is a cross-sectional, observational, prospective, multicentre study, conduct in France among a representative sample of anesthesiologists.
The factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) will be assessed in patients undergoing an outpatient surgery. Data will be collected by the physician during the inclusion visit (peripostoperative consultation). Additional data regarding the patient's perception (pain and satisfaction) will be collected using a self-questionnaire 7 days after the surgery.
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 |
|---|---|---|
| SA | Patients undergoing spinal anesthesia | |
| GA | Patients undergoing short general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia
All proposed factors will be described using a 4-levels verbal scale (decisive / important / of little importance / unimportant). The factors will be described from the questionnaire completed by the investigator during the inclusion visit, before the surgery.
Decisive factors for the choice of anesthesia will be described and compared between the two subgroups.spinal anesthesia and short general anesthesia.
Measured: During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit
Secondary outcomes (6)
Patients' characteristics in each subgroups
Patients' characteristics (demographic data, ASA physical status, risk factors...) will be described from the questionnaire completed by the investigator during the inclusion visit, before the surgery.
Measured: At the time of the perioperative consultation prior to their surgery (start of the inclusion visit or baseline visit)
Postoperative period from waking up to eligibility for discharge from hospital according to the type of anesthesia
Will be described from the questionnaire completed by the investigator during the inclusion visit, after the surgery.
Measured: Up to 24h after the surgery
Patients' satisfaction according to the type of anesthesia based on 2 questions using a 4-levels verbal scale
Will be described from the self-questionnaire completed by the patient 7 days after the surgery.
Measured: 7 days after surgery (i.e. 7 days after the inclusion)
Patients' pain according to the type of anesthesia using a VAS scale
Will be described from the self-questionnaire completed by the patient 7 days after the surgery.
Measured: Up to 7 days after surgery
Costs of spinal and general anesthesia
Will be described from the questionnaire completed by the investigator during the inclusion visit.
Measured: The day of the surgery
Use and safety of Baritekal® (prilocaine) if applicable
Modalities of spinal anesthesia with prilocaine. Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with prilocaine.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hélène HERMAN-DEMARS, MD, Study director, Nordic Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529501
- Sponsor's protocol ID
- BAG
- Acronym
- BAG
- Status last verified
- May 2016
- First submitted
- 27 Jul 2015
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Factors Determining the Choice of Spinal Versus General Anesthesia in Patients Undergoing Ambulatory Surgery: Results of a Multicenter Observational Study. Adv Ther. 2020 Jan;37(1):527-540. doi: 10.1007/s12325-019-01171-6. Epub 2019 Dec 11.
PubMed 31828612
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Choice of Anesthesia (Spinal Anesthesia or Short General Anesthesia) in Outpatient Surgery
- ClinicalTrials.gov ID
- NCT02529501
- Acronym / sponsor ID
- BAG / BAG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Nordic Pharma SASIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Aug 2015 (estimated)
- 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.
The purpose of this study is to describe, in real-life conditions, the factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient surgery.
Detailed description
This is a cross-sectional, observational, prospective, multicentre study, conduct in France among a representative sample of anesthesiologists.
The factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) will be assessed in patients undergoing an outpatient surgery. Data will be collected by the physician during the inclusion visit (peripostoperative consultation). Additional data regarding the patient's perception (pain and satisfaction) will be collected using a self-questionnaire 7 days after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SA | – | –Patients undergoing spinal anesthesia |
| GA | – | –Patients undergoing short general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery under spinal anesthesia or short general anesthesia will be informed about the study and will be asked to participate.
Key inclusion criteria (4 listed)
- Adult patients undergoing an ambulatory surgery
- Patients for whom either a spinal anesthesia or a short general anesthesia is planned
- Patients accepting and able to complete a self-administered questionnaire in French language
- Informed patients who accept the computer processing of their medical data and their right of access and correction
Key exclusion criteria (5 listed)
- Patients with contra-indications to elective ambulatory surgery
- Emergency surgeries
- Patient for which both spinal anesthesia and short general anesthesia coexist
- Patients with contra-indications to spinal anesthesia (due to surgical procedure site, comorbidities or patient's treatment)
- Patients participating or having participated in the previous month in a clinical trial in anaesthesiology
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
Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia
Time frame: During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit
All proposed factors will be described using a 4-levels verbal scale (decisive / important / of little importance / unimportant). The factors will be described from the questionnaire completed by the investigator during the inclusion visit, before the surgery. Decisive factors for the choice of anesthesia will be described and compared between the two subgroups.spinal anesthesia and short general anesthesia.
6 secondary outcomes
Patients' characteristics in each subgroups
Time frame: At the time of the perioperative consultation prior to their surgery (start of the inclusion visit or baseline visit)
Postoperative period from waking up to eligibility for discharge from hospital according to the type of anesthesia
Time frame: Up to 24h after the surgery
Patients' satisfaction according to the type of anesthesia based on 2 questions using a 4-levels verbal scale
Time frame: 7 days after surgery (i.e. 7 days after the inclusion)
Patients' pain according to the type of anesthesia using a VAS scale
Time frame: Up to 7 days after surgery
Costs of spinal and general anesthesia
Time frame: The day of the surgery
Use and safety of Baritekal® (prilocaine) if applicable
Time frame: During surgery
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 18 Nov 2016.
- Derived from this study: PubMed 31828612Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Factors Determining the Choice of Spinal Versus General Anesthesia in Patients Undergoing Ambulatory Surgery: Results of a Multicenter Observational Study. Adv Ther. 2020 Jan;37(1):527-540. doi: 10.1007/s12325-019-01171-6. Epub 2019 Dec 11.
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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.
Hélène HERMAN-DEMARS, MD study director
Nordic Pharma
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 Spinal Anesthesia and Short General Anesthesia, run by Nordic Pharma SAS 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 18 Nov 2016. 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?
Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia (time frame: During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529501, which also lists 1 linked publication.
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 18 Nov 2016; AzTrials last refreshed its copy on 28 Oct 2026.