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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

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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

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).

Condition or disease Intervention/treatment Phase
Cardiovascular Drug: Oxycodone 10mg Drug: Sufentanil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : September 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxycodone group Drug: Oxycodone 10mg
induction with 0.3mg/kg of oxycodone in general anesthesia

Experimental: Sufentanil group Drug: Sufentanil
induction with 0.3 µg/kg of Sufentanil in general anesthesia




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121416


Locations
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China, Liao Ning
shengjing hospital of China medical university
Shenyang, Liao Ning, China, 110004
Sponsors and Collaborators
Shengjing Hospital
Investigators
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Study Director: Junchao Zhu Shengjing Hospital

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Responsible Party: Yanchao Yang, Principal Investigator, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT04121416     History of Changes
Other Study ID Numbers: Oxycodone VS Sufentanil
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: April 2019

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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
Keywords provided by Yanchao Yang, Shengjing Hospital:
Oxycodone
Sufentanil
tracheal intubation
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sufentanil
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics