Spinal Versus General Anesthesia for Ambulatory Anesthesia
- Conditions
- Short General AnesthesiaOutpatient SurgerySpinal Anesthesia
- Registration Number
- NCT02529501
- Lead Sponsor
- Nordic Pharma SAS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 595
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia 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.
- Secondary Outcome Measures
Name Time Method Use and safety of Baritekal® (prilocaine) if applicable During surgery Modalities of spinal anesthesia with prilocaine. Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with prilocaine.
Patients' characteristics in each subgroups 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.
Patients' pain according to the type of anesthesia using a VAS scale Up to 7 days after surgery Will be described from the self-questionnaire completed by the patient 7 days after the surgery.
Costs of spinal and general anesthesia The day of the surgery Will be described from the questionnaire completed by the investigator during the inclusion visit.
Postoperative period from waking up to eligibility for discharge from hospital according to the type of anesthesia Up to 24h after the surgery Will be described from the questionnaire completed by the investigator during the inclusion visit, 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) Will be described from the self-questionnaire completed by the patient 7 days after the surgery.
Trial Locations
- Locations (1)
Nordic Pharma
🇫🇷Paris, France