Off-hours AnesthesiaNCT04957121
Comparison of On-hours Versus Off-hours Anesthesia of Hip Surgery
An observational study of Off-hours Anesthesia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
To explore the impact of the begin time of anesthesia on in-hospital mortality and early prognosis of patients undergoing hip surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Off-hours Anesthesia
- What is being tested?
- on-hours and off-hours
- How many people
- 1,843 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2021to 20 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had hip surgery during on-hours or off-hours.
Who may be able to join
- All patients who had hip surgery between January 1, 2015, and December 31, 2020 in Tongji Hospital.
Who cannot join
- under 18 years old
- had incomplete perioperative data
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: 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.
Read the 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.
- Conditions
- Off-hours Anesthesia
- Being tested
- on-hours, off-hours
- Keywords
- off-hours, hip surgery, perioperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-hoursOther
If the begin time of anesthesia was between 8:00 to 17:59, it was defined as "on-hours".
off-hoursOther
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".
| Study group | Role | What they receive |
|---|---|---|
| on-hours | Hip surgeries with the start time of anesthesia between 8:00 and 17:59 were coded as "on-hours". Receives: Other: 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". Receives: Other: off-hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
the mortality during hospitalization
Measured: up to 7 months
Secondary outcomes (7)
postoperative LOS
postoperative hospital length of stay
Measured: up to 4 months postoperatively
total LOS
total hospital length of stay
Measured: up to 7 months
ICU admission
the ratio of ICU admission
Measured: within 3 days postoperatively
postoperative complications
including renal dysfunction, anemia, hypotension, deep vein thrombosis, arrhythmia, coronary artery disease or heart failure, pulmonary infection, electrolyte disturbance, hyoxemia and delirium
Measured: within 3 days postoperatively
intraoperative fluid management
including blood loss, urine volume, concentrated red blood cells, fresh frozen plasma, equilibrium liquid and colloidal solution
Measured: intraoperative
intraoperative sufentanil
the dosage of intraoperative sufentanil
Measured: intraoperative
using vasoactive drugs
whether using vasoactive drugs or not intraoperatively
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start2 Jul 2021
- Primary completion8 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Off-hours AnesthesiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957121
- Sponsor's protocol ID
- TJ-IRB20210305
- Status last verified
- Aug 2021
- First submitted
- 21 Jun 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthesia Beginning at On-hours Versus Off-hours on Outcomes in Patients Undergoing Hip Surgery
- ClinicalTrials.gov ID
- NCT04957121
- Acronym / sponsor ID
- TJ-IRB20210305
- Conditions
- Off-hours Anesthesia
- Keywords
- off-hours, hip surgery, perioperative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,843 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 8 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the impact of the begin time of anesthesia on in-hospital mortality and early prognosis of patients undergoing hip surgery.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on-hours | – | Other: on-hoursHip surgeries with the start time of anesthesia between 8:00 and 17:59 were coded as "on-hours". |
| off-hours | – | Other: off-hoursHip 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had hip surgery during on-hours or off-hours.
Key inclusion criteria (1 listed)
- All patients who had hip surgery between January 1, 2015, and December 31, 2020 in Tongji Hospital.
Key exclusion criteria (2 listed)
- under 18 years old
- had incomplete perioperative data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| on-hoursIf the begin time of anesthesia was between 8:00 to 17:59, it was defined as "on-hours". | Other | on-hours |
| off-hoursIf 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". | Other | off-hours |
Primary outcome
in-hospital mortality
Time frame: up to 7 months
the mortality during hospitalization
7 secondary outcomes
postoperative LOS
Time frame: up to 4 months postoperatively
total LOS
Time frame: up to 7 months
ICU admission
Time frame: within 3 days postoperatively
postoperative complications
Time frame: within 3 days postoperatively
intraoperative fluid management
Time frame: intraoperative
intraoperative sufentanil
Time frame: intraoperative
using vasoactive drugs
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Off-hours Anesthesia
RecruitingObservational study
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Extubation Failures, Extubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Mei principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Off-hours Anesthesia, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.