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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular
• Intervention / Treatment: Drug: Oxycodone 10mg; Drug: Sufentanil

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: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liao Ning
    • Shenyang, Liao Ning, China, 110004
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): September 19, 2019

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sufentanil; tracheal intubation; Oxycodone
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Oxycodone; Sufentanil
• Other Study ID Numbers: Oxycodone VS Sufentanil

Drug and device information, study documents

• 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