Skip to main content
OpenTrials
Completed

NCT Number: NCT02529501

Spinal Versus General Anesthesia for Ambulatory Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Anesthesia Outpatient Surgery Short General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nordic Pharma

Paris, 75007, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia

    Time frame: 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 outcomes

  1. Patients' characteristics in each subgroups

    Time frame: 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.

  2. Postoperative period from waking up to eligibility for discharge from hospital according to the type of anesthesia

    Time frame: Up to 24h after the surgery

    Will be described from the questionnaire completed by the investigator during the inclusion visit, after the surgery.

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

    Time frame: 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.

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

    Time frame: Up to 7 days after surgery

    Will be described from the self-questionnaire completed by the patient 7 days after the surgery.

  5. Costs of spinal and general anesthesia

    Time frame: The day of the surgery

    Will be described from the questionnaire completed by the investigator during the inclusion visit.

  6. Use and safety of Baritekal® (prilocaine) if applicable

    Time frame: During surgery

    Modalities of spinal anesthesia with prilocaine. Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with prilocaine.

Sponsors and collaborators

Lead sponsor

Nordic Pharma SAS

Industry

Registry information

Official study title

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

Acronym: BAG

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2015
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.