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

May 22, 2023 updated by: Qing-he Zhou, Affiliated Hospital of Jiaxing University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Qinghe Zhou
  • Phone Number: +8613732573379
  • Email: jxxmxy@163.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Jiaxing, Zhejiang, China, 314000
        • Recruiting
        • Affiliated Hospital of Jiaxing University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-attempt success rate
Time Frame: During radial artery cannulation (up to 1 hour)
Success at the first skin puncture
During radial artery cannulation (up to 1 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall attempt
Time Frame: During radial artery cannulation (up to 1 hour)
Number of attempt of radial artery cannulation
During radial artery cannulation (up to 1 hour)
Overall Procedure time
Time Frame: During radial artery cannulation (up to 1 hour)
From ultrasound guidance, to Arterial waveform
During radial artery cannulation (up to 1 hour)
Complication rate
Time Frame: After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)
Hematoma, Distal ischemia, Spasm accessed by ultrasound
After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)
Overall success rate
Time Frame: During radial artery cannulation (up to 1 hour)
success rate of puncture and catheter placement within 5 minutes.
During radial artery cannulation (up to 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Jiaxing University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KY-297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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