General AnesthesiaNCT02822417
Clinical and Genetic Factors on the Postoperative Recovery Time of General Anaesthesia
An observational study of General Anesthesia, run by Yijing He at 1 site in China.
Trial summary
To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Anesthesia
- How many people
- 1,453 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 31 Dec 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Laparoscopic surgery, orthopedics surgery or open surgery patients in Chinese
Who may be able to join
- Aged more than 18 years;
- General anesthesia for all patients;
- Patients underwent surgery for laparoscopic surgery, orthopedics surgery or open surgery;
- Patients were not delivered allogeneic blood in three months;
- Having the ability to understand and sign the informed consent.
Who cannot join
- Pregnant or lactating women;
- Having an immune deficiency, as a patient with HIV infection;
- Patients with infectious diseases, such as syphilis;
- Patients delivered allogeneic blood in three months;
- Researchers believe that may increasing the risk of subjects or interfering clinical trial;
- Don't have the ability to understand or sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia.
Read the detailed description
Recovery time of postoperative anesthesia is an important index to reflect patient's postoperative health status. The investigators want to collect patients' clinical dates and their blood samples, then extract DNA from blood samples, acquire every patients' genetic variation information. Finally, acquiring the mathematical model of the influence of clinical factors and genetic factors on the recovery time after operation, predicting the recovery time of anesthesia.
- Conditions
- General Anesthesia
- Keywords
- Recover time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients after general anesthesia | Laparoscopic surgery, orthopedics surgery or open surgery patients after general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recover time of anesthesia
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start1 Jun 2016
- Primary completion10 Oct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yijing He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yijing He, Central South University
- Investigators
- Yijing He, MD,PhD, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822417
- Sponsor's protocol ID
- 2016 MZ/CSU/PS
- Status last verified
- Jul 2018
- First submitted
- 30 Jun 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: data not entered
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Genetic Factors on the Postoperative Recovery Time of General Anaesthesia
- ClinicalTrials.gov ID
- NCT02822417
- Acronym / sponsor ID
- 2016 MZ/CSU/PS
- Conditions
- General Anesthesia
- Keywords
- Recover time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,453 participants (actual)
- Lead sponsor
- Yijing HeUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 4 Jul 2016 (estimated)
- 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 evaluate the effect of clinical factors on the recovery time of postoperative anesthesia and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia.
Detailed description
Recovery time of postoperative anesthesia is an important index to reflect patient's postoperative health status. The investigators want to collect patients' clinical dates and their blood samples, then extract DNA from blood samples, acquire every patients' genetic variation information. Finally, acquiring the mathematical model of the influence of clinical factors and genetic factors on the recovery time after operation, predicting the recovery time of anesthesia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients after general anesthesia | – | –Laparoscopic surgery, orthopedics surgery or open surgery patients after general anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Laparoscopic surgery, orthopedics surgery or open surgery patients in Chinese
Key inclusion criteria (5 listed)
- Aged more than 18 years;
- General anesthesia for all patients;
- Patients underwent surgery for laparoscopic surgery, orthopedics surgery or open surgery;
- Patients were not delivered allogeneic blood in three months;
- Having the ability to understand and sign the informed consent.
Key exclusion criteria (6 listed)
- Pregnant or lactating women;
- Having an immune deficiency, as a patient with HIV infection;
- Patients with infectious diseases, such as syphilis;
- Patients delivered allogeneic blood in three months;
- Researchers believe that may increasing the risk of subjects or interfering clinical trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recover time of anesthesia
Time frame: within 24 hours
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 10 Jul 2018.
- Individual participant dataSharing planned: Undecided. data not entered
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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.
Yijing He, MD,PhD principal investigator
Xiangya Hospital of Central South University
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 General Anesthesia, run by Yijing He 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 5 inclusion and 6 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 10 Jul 2018. 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?
Recover time of anesthesia (time frame: within 24 hours). 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 10 Jul 2018.