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Spinal Versus General Anesthesia for Ambulatory Anesthesia

Completed
Conditions
Short General Anesthesia
Outpatient Surgery
Spinal 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
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
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesiaDuring 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
NameTimeMethod
Use and safety of Baritekal® (prilocaine) if applicableDuring 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 subgroupsAt 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 scaleUp 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 anesthesiaThe 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 anesthesiaUp 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 scale7 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

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