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Trial record 19 of 683 for:    OXYCODONE

Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery

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: NCT04121416
Recruitment Status : Completed
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yanchao Yang, Shengjing Hospital

Tracking Information
First Submitted Date  ICMJE October 2, 2019
First Posted Date  ICMJE October 9, 2019
Last Update Posted Date October 9, 2019
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP) [ Time Frame: one second before anesthesia induction, the moment when tracheal catheter passes through glottis and at 1, 3, 5 min after tracheal intubation ]
Under local anesthesia invasive artery line was put to the patients to monitor systolic blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery
Official Title  ICMJE Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery
Brief Summary To evaluate the effect of oxycodone and sufentanil in preventing cardiovascular responses to tracheal intubation in the patients with coronary heart disease (CHD).
Detailed Description Laryngoscopy and tracheal intubation can provoke an increase of blood pressure (BP) and/or HR [1.2]. This hemodynamic stress may lead to an imbalance between myocardial oxygen consumption and supply and therefore induce myocardial ischemia, which may be endurable in the patients with normal cardiovascular condition but is potential harmful to the patients with coronary heart disease. Thus it is critical to attenuate the cardiovascular stress induced by laryngoscopy and endotracheal intubation in the high risk patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Cardiovascular
Intervention  ICMJE
  • Drug: Oxycodone 10mg
    induction with 0.3mg/kg of oxycodone in general anesthesia
  • Drug: Sufentanil
    induction with 0.3 µg/kg of Sufentanil in general anesthesia
Study Arms  ICMJE
  • Experimental: Oxycodone group
    Intervention: Drug: Oxycodone 10mg
  • Experimental: Sufentanil group
    Intervention: Drug: Sufentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2019)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 19, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The coronary angiography from each patient showed that lesions exist in at least one main coronary artery

Exclusion Criteria:

a history of reactive airway disease, gastroesophageal reflux, morbid obesity, a known or predicted difficult airway

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04121416
Other Study ID Numbers  ICMJE Oxycodone VS Sufentanil
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanchao Yang, Shengjing Hospital
Study Sponsor  ICMJE Shengjing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Junchao Zhu Shengjing Hospital
PRS Account Shengjing Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP