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General Anesthetic Mode and Postoperative Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335579
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Yan Zhou, MD, Peking University First Hospital

Brief Summary:
The relationship between anesthetic medication and postoperative major cardiac and cerebral complications will be studied using logistic regression model.

Condition or disease Intervention/treatment
Anesthesia Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil

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.

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Study Type : Observational
Actual Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship Between General Anesthetic Mode and Postoperative Severe Cardiovascular and Cerebrovascular Complications: a Retrospective Cohort Study
Actual Study Start Date : December 31, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : October 10, 2017

Group/Cohort Intervention/treatment
non-MACE
patients without major postoperative cardiac or cerebral complications
Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil
Different combination of opioids and anesthetics

MACE
patients with major postoperative cardiac or cerebral complications
Combination Product: inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil
Different combination of opioids and anesthetics




Primary Outcome Measures :
  1. Major cardiac complication [ Time Frame: 90 days after surgery ]
    major cardiac event



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients for non-cardiac surgery under general anesthesia
Criteria

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.
Publications:
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Responsible Party: Yan Zhou, MD, Principal Investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03335579    
Other Study ID Numbers: GATCIMACE
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sufentanil
Remifentanil
Propofol
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia