- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04957121
Comparison of On-hours Versus Off-hours Anesthesia of Hip Surgery
August 20, 2021 updated by: Wei Mei, Huazhong University of Science and Technology
Comparison of Anesthesia Beginning at On-hours Versus Off-hours on Outcomes in Patients Undergoing Hip Surgery
To explore the impact of the begin time of anesthesia on in-hospital mortality and early prognosis of patients undergoing hip surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The patients undergoing hip surgery between were divided into the on-hours group or the off-hours group depending on the begin time of anesthesia in this retrospective cohort study.
In-hospital mortality and early prognosis were compared between the two groups.
Study Type
Observational
Enrollment (Actual)
1843
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430030
- Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who had hip surgery during on-hours or off-hours.
Description
Inclusion Criteria:
- All patients who had hip surgery between January 1, 2015, and December 31, 2020 in Tongji Hospital.
Exclusion Criteria:
- under 18 years old
- had incomplete perioperative data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
on-hours
Hip surgeries with the start time of anesthesia between 8:00 and 17:59 were coded as "on-hours".
|
If the begin time of anesthesia was between 8:00 to 17:59, it was defined as "on-hours".
|
|
off-hours
Hip surgeries with anesthesia beginning between 18:00 and 7:59 were coded as "off-hours".
Besides, taking the long duration of hip surgery into account, if the anesthesia began before 18:00 but ended after 20:00, it was also defined as "off-hours".
|
If the start time of anesthesia was between 18:00 to 7:59 or the end time of anesthesia was later than 20:00, it was defined as "off-hours".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
in-hospital mortality
Time Frame: up to 7 months
|
the mortality during hospitalization
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up to 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative LOS
Time Frame: up to 4 months postoperatively
|
postoperative hospital length of stay
|
up to 4 months postoperatively
|
|
total LOS
Time Frame: up to 7 months
|
total hospital length of stay
|
up to 7 months
|
|
ICU admission
Time Frame: within 3 days postoperatively
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the ratio of ICU admission
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within 3 days postoperatively
|
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postoperative complications
Time Frame: within 3 days postoperatively
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including renal dysfunction, anemia, hypotension, deep vein thrombosis, arrhythmia, coronary artery disease or heart failure, pulmonary infection, electrolyte disturbance, hyoxemia and delirium
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within 3 days postoperatively
|
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intraoperative fluid management
Time Frame: intraoperative
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including blood loss, urine volume, concentrated red blood cells, fresh frozen plasma, equilibrium liquid and colloidal solution
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intraoperative
|
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intraoperative sufentanil
Time Frame: intraoperative
|
the dosage of intraoperative sufentanil
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intraoperative
|
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using vasoactive drugs
Time Frame: intraoperative
|
whether using vasoactive drugs or not intraoperatively
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wei Mei, Tongji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2021
Primary Completion (Actual)
August 8, 2021
Study Completion (Actual)
August 20, 2021
Study Registration Dates
First Submitted
June 21, 2021
First Submitted That Met QC Criteria
June 30, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Actual)
August 23, 2021
Last Update Submitted That Met QC Criteria
August 20, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TJ-IRB20210305
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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