Spinal Versus General Anesthesia for Ambulatory Anesthesia

NCT02529501 | Completed

• 1 other identifier: BAG
• Study Type: observational
• Target: 595
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Anesthesia; Short General Anesthesia; Outpatient Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patients' characteristics in each subgroups

  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

  Up to 24h after the surgery

• Patients' satisfaction according to the type of anesthesia based on 2 questions using a 4-levels verbal scale

  7 days after surgery (i.e. 7 days after the inclusion)

• Patients' pain according to the type of anesthesia using a VAS scale

  Up to 7 days after surgery

• Costs of spinal and general anesthesia

  The day of the surgery

Study Arms (2)

SA

Patients undergoing spinal anesthesia

GA

Patients undergoing short general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordic Pharma SAS: lead

Study Sites (1)

Nordic Pharma

Paris, 75007, France

Location

Related Publications (1)

• 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.

  PMID: 31828612 DERIVED

Study Officials

• Hélène HERMAN-DEMARS, MD

  Nordic Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 20, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 18, 2016

Record last verified: 2016-05

Locations

FR (1)