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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04121416
Other study ID # Oxycodone VS Sufentanil
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date September 19, 2019

Study information

Verified date April 2019
Source Shengjing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effect of oxycodone and sufentanil in preventing cardiovascular responses to tracheal intubation in the patients with coronary heart disease (CHD).


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 19, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 60 Years to 85 Years
Eligibility 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

Study Design


Intervention

Drug:
Oxycodone 10mg
induction with 0.3mg/kg of oxycodone in general anesthesia
Sufentanil
induction with 0.3 µg/kg of Sufentanil in general anesthesia

Locations

Country Name City State
China shengjing hospital of China medical university Shenyang Liao Ning

Sponsors (1)

Lead Sponsor Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) one second before anesthesia induction, the moment when tracheal catheter passes through glottis and at 1, 3, 5 min after tracheal intubation
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