Patients Needed Surgery and AnesthesiaNCT02440269
The Effect of Circadian Rhythms on Norctrend Index in Anesthesia
An observational study of Patients Needed Surgery and Anesthesia and Except on the Head or Facial Surgery, run by Lu KZ at 1 site in China.
Trial summary
The purpose of this study is to determine whether the Circadian Rhythms effects on the Norctrend Index in Anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients Needed Surgery and Anesthesia, Except on the Head or Facial Surgery
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Jul 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who receive surgery and general anesthesia
Who may be able to join
- American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
- ability to compliance the research plan;
- volunteered and signed for the study ;
- receive surgery and general anesthesia
Who cannot join
- ASA>Ⅱ;
- Head or facial surgery
- can't collaborate;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Southwest Hospital Third Military Medical University
Chongqing, Chongqing Municipality, 400038
lu kai zhi, phd, +8613637962143, 304365565@qq.com
About this study
The purpose of this study is to determine whether the Circadian Rhythms effects on the Norctrend Index in Anesthesia.
Read the detailed description
It has been reported that circadian rhythm has many aspects of influence on human body. But little is knew about the circadian rhythm affect on Narcotrend index (made in Germany) in total intravenous anesthesia .The investigators' study is to find the relationship between them.
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 |
|---|---|---|
| A：day | the patients who receive surgery and anesthesia during 8:00 am to 6:00 pm | |
| B：night | the patients who receive surgery and anesthesia during 10:00 pm to 5:00 am next day |
What is being measured
The primary outcome is the main question the study is designed to answer.
narcotrend index
the narcotrend index we recorded during the surgery and anesthesia in appropriate depth of anesthesia
Measured: during operation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Needed Surgery and 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu KZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu KZ, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440269
- Sponsor's protocol ID
- narcotrend
- Status last verified
- May 2015
- First submitted
- 3 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shen JH, Ye M, Chen Q, Chen Y, Zhao HL, Khan A, Yi B, Ning JL, Lu KZ, Gu JT. Effects of circadian rhythm on Narcotrend index and target-controlled infusion concentration of propofol anesthesia. BMC Anesthesiol. 2021 Sep 6;21(1):215. doi: 10.1186/s12871-021-01445-z.
PubMed 34488646
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Circadian Rhythms on Norctrend Index in Anesthesia
- ClinicalTrials.gov ID
- NCT02440269
- Acronym / sponsor ID
- narcotrend
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lu KZUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 12 May 2015 (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.
The purpose of this study is to determine whether the Circadian Rhythms effects on the Norctrend Index in Anesthesia.
Detailed description
It has been reported that circadian rhythm has many aspects of influence on human body. But little is knew about the circadian rhythm affect on Narcotrend index (made in Germany) in total intravenous anesthesia .The investigators' study is to find the relationship between them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A：day | – | –the patients who receive surgery and anesthesia during 8:00 am to 6:00 pm |
| B：night | – | –the patients who receive surgery and anesthesia during 10:00 pm to 5:00 am next day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who receive surgery and general anesthesia
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;
- ability to compliance the research plan;
- volunteered and signed for the study ;
- receive surgery and general anesthesia
Key exclusion criteria (3 listed)
- ASA>Ⅱ;
- Head or facial surgery
- can't collaborate;
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
narcotrend index
Time frame: during operation time
the narcotrend index we recorded during the surgery and anesthesia in appropriate depth of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Derived from this study: PubMed 34488646Shen JH, Ye M, Chen Q, Chen Y, Zhao HL, Khan A, Yi B, Ning JL, Lu KZ, Gu JT. Effects of circadian rhythm on Narcotrend index and target-controlled infusion concentration of propofol anesthesia. BMC Anesthesiol. 2021 Sep 6;21(1):215. doi: 10.1186/s12871-021-01445-z.
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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.
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 Patients Needed Surgery and Anesthesia and Except on the Head or Facial Surgery, run by Lu KZ 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lu kai zhi, phd (+8613697962143, 304365565@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
narcotrend index (time frame: during operation time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440269, which also lists 1 linked publication.
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 12 May 2015.