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NCT04863599 Clinical Trial

Patient Experience With OMS Procedures Regarding Anesthesia

Patient Satisfaction Clinical Trial

Official title:
Patient Experience With OMS Procedures Under General Anesthesia Compared to Sedation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04863599
Other study ID # Z-2021038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 24, 2021
Est. completion date September 21, 2021

Study information
Verified date April 2023
Source Ziekenhuis Oost-Limburg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of the study is to know more about the experience/satisfaction of patients undergoing oral and maxillofacial surgery (OMS). Depending on the type of procedure, the patient will receive a sedation or a general anesthesia. At the first day post-operatively, patients will be contacted to complete a questionnaire. The questionnaire will be subdivided into anaesthesia-related discomfort and anaesthesia care in general.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date September 21, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - OMS procedure - signed informed consent - Age above 12 years Exclusion Criteria: - need for post-operative hospitalization - mental disorder with no capability of filling in questionnaires

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
Patients will be asked to complete the Bauer and Brice questionnaire at post-operative day 1.

Locations
Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk

Sponsors (1)
Lead Sponsor Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bauer questionnaire at post-operative day 1 The Bauer questionnaire contains a set of questions on anaesthesia-related discomfort and another set on satisfaction with anaesthesia care in general. The questions on discomfort will be assessed on a 3-point scale, and those on patient satisfaction on a 4-point scale. post-operative day 1
Primary Brice questionnaire at post-operative day 1 The questionnaire attempts to identify patients who may have had memories of their operation i.e. accidental awareness under anesthesia. These are open questions. post-operative day 1
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