NCT04121416

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
Last Updated

October 9, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

October 2, 2019

Last Update Submit

October 8, 2019

Conditions

Cardiovascular

Keywords

OxycodoneSufentaniltracheal intubation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Oxycodone group

EXPERIMENTAL
Drug: Oxycodone 10mg

Sufentanil group

EXPERIMENTAL
Drug: Sufentanil

Interventions

Oxycodone 10mgDRUG

induction with 0.3mg/kg of oxycodone in general anesthesia

Oxycodone group
SufentanilDRUG

induction with 0.3 µg/kg of Sufentanil in general anesthesia

Sufentanil group

Eligibility Criteria

Age60 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

shengjing hospital of China medical university

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Interventions

OxycodoneSufentanil

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsFentanylPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Junchao Zhu

    Shengjing Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 9, 2019

Study Start

April 1, 2019

Primary Completion

August 31, 2019

Study Completion

September 19, 2019

Last Updated

October 9, 2019

Record last verified: 2019-04

Locations

CN(1)