An observational study in Spinal Anesthesia, Short General Anesthesia and Outpatient Surgery, sponsored by Nordic Pharma SAS. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Nordic Pharma SAS · Observational
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.
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.
Nordic Pharma SAS is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for surgery under spinal anesthesia or short general anesthesia will be informed about the study and will be asked to participate.
Exclusion Criteria:
Patients undergoing spinal anesthesia
Patients undergoing short general anesthesia
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.
Time frame: During the perioperative consultation (patients are included at the time of the perioperative consultation prior to their surgery): baseline visit
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.
Time frame: At the time of the perioperative consultation prior to their surgery (start of the inclusion visit or baseline visit)
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.
Time frame: Up to 24h after the surgery
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.
Time frame: 7 days after surgery (i.e. 7 days after the inclusion)
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.
Time frame: Up to 7 days after surgery
Costs of spinal and general anesthesia
Will be described from the questionnaire completed by the investigator during the inclusion visit.
Time frame: The day of the surgery
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.
Time frame: During surgery
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Nordic Pharma SAS