Spinal Versus General Anesthesia for Ambulatory Anesthesia (BAG)

November 17, 2016 updated by: Nordic Pharma SAS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
595

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75007
        • Nordic Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
SA
Patients undergoing spinal anesthesia
GA
Patients undergoing short general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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
Will be described from the questionnaire completed by the investigator during the inclusion visit, after the surgery.
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)
Will be described from the self-questionnaire completed by the patient 7 days after the surgery.
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
Will be described from the self-questionnaire completed by the patient 7 days after the surgery.
Up to 7 days after surgery
Costs of spinal and general anesthesia
Time Frame: The day of the surgery
Will be described from the questionnaire completed by the investigator during the inclusion visit.
The day of the surgery
Use and safety of Baritekal® (prilocaine) if applicable
Time Frame: During surgery
Modalities of spinal anesthesia with prilocaine. Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with prilocaine.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nordic Pharma SAS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hélène HERMAN-DEMARS, MD, Nordic Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BAG

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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