Spinal Versus General Anesthesia for Ambulatory Anesthesia

Spinal Anesthesia Clinical Trial

— BAG  

Official title:

Factors Influencing the Choice of Anesthesia (Spinal Anesthesia or Short General Anesthesia) in Outpatient Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529501
• Other study ID #: BAG
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: November 17, 2016
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: Nordic Pharma SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Conseil National de l'Ordre des MédecinsFrance: French Data Protection Authority
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Outpatient Surgery
• Short General Anesthesia
• Spinal Anesthesia

Locations

Country	Name	City	State
France	Nordic Pharma	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Pharma SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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	Yes
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes