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Dezoxide Suppresses Sufentanil-induced Cough

Primary Purpose

Sufentanil-induced Cough

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intravenous dizocine
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sufentanil-induced Cough

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18~80 years old; Sex is not limited; ASA class II~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form

Exclusion Criteria:

  • Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control

    Dezocine

    Arm Description

    intravenous dezocine (0.03mg/kg diluted to 5 ml)

    Outcomes

    Primary Outcome Measures

    sufentanil-induced cough
    rate and severity of cough after sufentanil injection

    Secondary Outcome Measures

    heart rate
    heart rate during induction of general anesthesia
    mean arterial pressure
    mean arterial pressure during induction of general anesthesia
    SpO2
    SpO2 during induction of general anesthesia

    Full Information

    First Posted
    September 1, 2022
    Last Updated
    September 4, 2022
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05532449
    Brief Title
    Dezoxide Suppresses Sufentanil-induced Cough
    Official Title
    Low-dose Dezoxide Suppresses Sufentanil-induced Cough During Induction of General Anesthesia in Patients Undergoing Cardiac Surgery: a Prospective, Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 12, 2022 (Anticipated)
    Primary Completion Date
    September 12, 2022 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (SpO2 <90%), or other expected effects. The number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sufentanil-induced Cough

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Title
    Dezocine
    Arm Type
    Experimental
    Arm Description
    intravenous dezocine (0.03mg/kg diluted to 5 ml)
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous dizocine
    Intervention Description
    Intravenous dizocine (0.03mg/kg diluted to 5 ml)
    Primary Outcome Measure Information:
    Title
    sufentanil-induced cough
    Description
    rate and severity of cough after sufentanil injection
    Time Frame
    2 minutes after intubation
    Secondary Outcome Measure Information:
    Title
    heart rate
    Description
    heart rate during induction of general anesthesia
    Time Frame
    2 minutes after intubation
    Title
    mean arterial pressure
    Description
    mean arterial pressure during induction of general anesthesia
    Time Frame
    2 minutes after intubation
    Title
    SpO2
    Description
    SpO2 during induction of general anesthesia
    Time Frame
    2 minutes after intubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18~80 years old; Sex is not limited; ASA class II~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form Exclusion Criteria: Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Dezoxide Suppresses Sufentanil-induced Cough

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