Clinical trial NCT02529501: Spinal Versus General Anesthesia for Ambulatory Anesthesia
Official title: Factors Influencing the Choice of Anesthesia (Spinal Anesthesia or Short General Anesthesia) in Outpatient Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia
Short General Anesthesia
Outpatient Surgery
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia
timeFrame: During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit
Secondary outcomes:
measure: Patients' characteristics in each subgroups
timeFrame: At the time of the perioperative consultation prior to their surgery (start of the inclusion visit or baseline visit)
measure: Postoperative period from waking up to eligibility for discharge from hospital according to the type of anesthesia
timeFrame: Up to 24h after the surgery
measure: Patients' satisfaction according to the type of anesthesia based on 2 questions using a 4-levels verbal scale
timeFrame: 7 days after surgery (i.e. 7 days after the inclusion)
measure: Patients' pain according to the type of anesthesia using a VAS scale
timeFrame: Up to 7 days after surgery
measure: Costs of spinal and general anesthesia
timeFrame: The day of the surgery
measure: Use and safety of Baritekal® (prilocaine) if applicable
timeFrame: During surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Nordic Pharma
Study officials:
affiliation: Nordic Pharma
name: Hélène HERMAN-DEMARS, MD
role: STUDY_DIRECTOR
References:
citation: 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.