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Safety and Feasibility of Reversible Induction Strategy

Sponsor
RenJi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04434963
Collaborator
(none)
20
Enrollment
1
Location
10
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study would explore the safety and feasibility of a reversible induction strategy for uncertain difficult airway. This reversible induction strategy would include high flow nasal canular oxygenation support, short-term effect anesthetic including Propofol and Remifentanil for sedation and analgesia and Sugammadex would be used for reverse the muscle relaxant.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Safety and Feasibility of Reversible Induction Strategy Supported by HFNC Combined With Specific Anesthetic
    Actual Study Start Date :
    Feb 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Successful rate of reversion [From the beginning of induction to 15min later]

    Secondary Outcome Measures

    1. TOFr 0.9 reversion time [From the beginning of induction to 15min later]

    2. BIS 80 reversion time [From the beginning of induction to 15min later]

    3. Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time [From the beginning of induction to 15min later]

    4. consciousness reversion time [From the beginning of induction to 15min later]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years old,<65 years old

    • Signed informed consent

    • Undergoing selective operation （ time of operation is over two hours）

    • ASA classification I-II

    • Mallampati classification 3-4

    • suspicious difficult airway, but the anesthetists decide to try to rapid induction

    Exclusion Criteria:

    • Patients with several dysfunctions of liver, kidney or heart)

    • Patients with a full stomach or have other risk factors of reflux aspiration

    • Any medicine was taken before surgery, which might enhance or mitigate the effects of muscle relaxant

    • Infection of the mouth or nose

    • Allergy history of any medicine which would be used in this study

    • Pregnant and lactating women

    • Patients with neuromuscular disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Study Director: diansan su, Renji Hospital, Shanghai Jiaotong University, Shanghai, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    diansan su, Principal Investigator, RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT04434963
    Other Study ID Numbers:
    • RenjiH6502
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by diansan su, Principal Investigator, RenJi Hospital
    THRIVE
    Uncertain difficult airway
    Reversible induction strategy
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Sep 14, 2021