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The Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Operators

Sponsor
Affiliated Hospital of Jiaxing University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05863455
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
12.5
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the effect of mild midazolam combined with sufentanil on radial artery cannulation in novice operators.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Primary outcome: first-attempt success rate of radial artery cannulation and catheter placement Secondary outcomes: number of attempt of radial artery cannulation, overall procedure time, overall success rate(success rate of puncture and catheter placement within 5 minutes), PSV, EDV, RI, TAmean, systolic and diastolic blood pressure before and after puncture, heart rate, patient comfort, pain score, incidence of local hematoma, thrombosis, and spasm.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Operators
Actual Study Start Date :
May 17, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: mild sedation and analgesia

Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation.

Drug: mild sedation and analgesia
Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation
Other Names:
  • sufentanil and midazolam

    		•
    Active Comparator: control

    Intravenous injection of an equivalent volume of saline before radial artery cannulation.

    Drug: control
    ntravenous injection of an equivalent volume of saline before radial artery cannulation.
    Other Names:
  • saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. First-attempt success rate [During radial artery cannulation (up to 1 hour)]

      Success at the first skin puncture

    Secondary Outcome Measures

    1. Overall attempt [During radial artery cannulation (up to 1 hour)]

      Number of attempt of radial artery cannulation

    2. Overall Procedure time [During radial artery cannulation (up to 1 hour)]

      From ultrasound guidance, to Arterial waveform

    3. Overall success rate [During radial artery cannulation (up to 1 hour)]

      success rate of puncture and catheter placement within 5 minutes.

    4. Complication rate [After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)]

      Hematoma, Distal ischemia, Spasm accessed by ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who required arterial cannulation for continuous blood pressure monitoring

    • Aged >20years

    • ASA physical status of 1-3

    • All patients agreed to participate in this study at the time of recruitment and signed an informed consent form.

    Exclusion Criteria:

    • without radial artery cannulation

    • positive modifed Allen's test

    • signs of infammation at the intended puncture site; coagulopathy

    • arterial disease (such as Raynaud's disease or thromboangitis obliterans); upper extremity or shoulder surgeries;

    • temporary use of vasoactive medication 30min before the measurement during the study

    • Patients with abnormal and curved arteries

    • Subjects with a history of chronic opioid or benzodiazepine use, known allergy, or adverse reactions to opioids or benzodiazepines.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated Hospital of Jiaxing University Jiaxing Zhejiang China 314000

    Sponsors and Collaborators

    • Affiliated Hospital of Jiaxing University

    Investigators

    • Principal Investigator: Qinghe Zhou, Affiliated Hospital of Jiaxing University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qing-he Zhou, Principal investigator, Affiliated Hospital of Jiaxing University
    ClinicalTrials.gov Identifier:
    NCT05863455
    Other Study ID Numbers:
    • 2023-KY-297
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 23, 2023
    Last Verified:
    May 1, 2023
    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 Qing-he Zhou, Principal investigator, Affiliated Hospital of Jiaxing University
    Radial Artery Cannulation
    Novice Operators
    Additional relevant MeSH terms:
    Agnosia
    Midazolam
    Sufentanil

    Study Results

    No Results Posted as of May 23, 2023