Spinal Versus General Anesthesia for Ambulatory Anesthesia (BAG)

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: Completed
• Conditions: Spinal Anesthesia; Outpatient Surgery; Short General Anesthesia

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: Observational
• Enrollment (Actual): 595

Contacts and Locations

Study Locations

• France
  • Paris, France, 75007
    • Nordic Pharma

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
SA; Patients undergoing spinal anesthesia
GA; Patients undergoing short general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	During surgery

Collaborators and Investigators

• Sponsor: Nordic Pharma SAS
• Investigators: Study Director: Hélène HERMAN-DEMARS, MD, Nordic Pharma

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BAG