- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03335579
General Anesthetic Mode and Postoperative Complications
November 3, 2017 updated by: Yan Zhou, MD, Peking University First Hospital
Relationship Between General Anesthetic Mode and Postoperative Severe Cardiovascular and Cerebrovascular Complications: a Retrospective Cohort Study
The relationship between anesthetic medication and postoperative major cardiac and cerebral complications will be studied using logistic regression model.
Study Overview
Status
Completed
Conditions
Detailed Description
The study group try to find out if there is a connection between the use of different anesthetic methods with different narcotic drugs and postoperative major cardiac and cerebral complications.
Study Type
Observational
Enrollment (Actual)
50000
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 to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients for non-cardiac surgery under general anesthesia
Description
Inclusion Criteria:
- non-cardiac surgery, with age> = 18 years old, ASA grade I-IV, under general anesthesia
Exclusion Criteria:
- non-general anesthesia, without the use of target-controlled infusion of remifentanil or sufentanil, absence of intraoperative or perioperative information.
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 |
---|---|
non-MACE
patients without major postoperative cardiac or cerebral complications
|
Different combination of opioids and anesthetics
|
MACE
patients with major postoperative cardiac or cerebral complications
|
Different combination of opioids and anesthetics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major cardiac complication
Time Frame: 90 days after surgery
|
major cardiac event
|
90 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Herling SF, Dreijer B, Wrist Lam G, Thomsen T, Moller AM. Total intravenous anaesthesia versus inhalational anaesthesia for adults undergoing transabdominal robotic assisted laparoscopic surgery. Cochrane Database Syst Rev. 2017 Apr 4;4(4):CD011387. doi: 10.1002/14651858.CD011387.pub2.
- Flier S, Post J, Concepcion AN, Kappen TH, Kalkman CJ, Buhre WF. Influence of propofol-opioid vs isoflurane-opioid anaesthesia on postoperative troponin release in patients undergoing coronary artery bypass grafting. Br J Anaesth. 2010 Aug;105(2):122-30. doi: 10.1093/bja/aeq111. Epub 2010 Jun 23.
- Min JJ, Kim G, Lee JH, Hong KY, Kim WS, Lee YT. Does the Type of Anesthetic Technique Affect In-Hospital and One-Year Outcomes after Off-Pump Coronary Arterial Bypass Surgery? PLoS One. 2016 Apr 7;11(4):e0152060. doi: 10.1371/journal.pone.0152060. eCollection 2016.
- Guclu CY, Unver S, Aydinli B, Kazanci D, Dilber E, Ozgok A. The effect of sevoflurane vs. TIVA on cerebral oxygen saturation during cardiopulmonary bypass--randomized trial. Adv Clin Exp Med. 2014 Nov-Dec;23(6):919-24. doi: 10.17219/acem/37339.
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)
December 31, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
October 10, 2017
Study Registration Dates
First Submitted
October 30, 2017
First Submitted That Met QC Criteria
November 3, 2017
First Posted (Actual)
November 7, 2017
Study Record Updates
Last Update Posted (Actual)
November 7, 2017
Last Update Submitted That Met QC Criteria
November 3, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GATCIMACE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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