Back to resultsComparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery
Primary Purpose
Cardiovascular
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oxycodone 10mg
Sufentanil
Sponsored by
About this trial
This is an interventional other trial for Cardiovascular focused on measuring Oxycodone, Sufentanil, tracheal intubation
Eligibility Criteria
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
Sites / Locations
- shengjing hospital of China medical university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oxycodone group
Sufentanil group
Arm Description
Outcomes
Primary Outcome Measures
blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP)
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04121416
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular
Keywords
Oxycodone, Sufentanil, tracheal intubation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycodone group
Arm Type
Experimental
Arm Title
Sufentanil group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxycodone 10mg
Intervention Description
induction with 0.3mg/kg of oxycodone in general anesthesia
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
induction with 0.3 µg/kg of Sufentanil in general anesthesia
Primary Outcome Measure Information:
Title
blood pressure(SBP)、diastolic blood pressure(DBP)、mean arterial pressure(MAP)
Description
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)
Time Frame
one second before anesthesia induction, the moment when tracheal catheter passes through glottis and at 1, 3, 5 min after tracheal intubation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junchao Zhu
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
shengjing hospital of China medical university
City
Shenyang
State/Province
Liao Ning
ZIP/Postal Code
110004
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs