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NCT Number: NCT05863455

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

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.

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Key information

Conditions

Sedation and Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

About this study

outcome: patients discomfort，visual analogue scale，First-attempt success rate，the success rate of radial artery cannulation within 10 minutes, Complication rate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who required arterial cannulation for continuous blood pressure monitoring
  • Aged >20years
  • ASA physical status of 1-3
  • BMI 18-28kg/m2
  • All patients agreed to participate in this study at the time of recruitment and signed an informed consent form.

Exclusion criteria

  • a positive Allen's test
  • infection at the puncture site
  • coagulation disorders; arterial diseases (such as Raynaud's disease or thromboangiitis obliterans)
  • use of vasoactive drugs within 30 minutes before measurement during the study
  • patients with arterial abnormalities and bends; hemorrhagic shock
  • arterial atherosclerosis; radial artery puncture within the past 30 days
  • chronic use of opioid or benzodiazepine drugs
  • and known allergies or adverse reactions to benzodiazepines or opioids.

Treatment and study plan

mild sedation and analgesia

Drug

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

Control

Drug

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

Other names: saline

Primary outcomes

  1. Overall success rate

    Time frame: During radial artery cannulation (up to 1 hour)

    success rate of puncture and catheter placement within 10 minutes.

Secondary outcomes

  1. patients discomfort

    Time frame: During radial artery cannulation (up to 1 hour)

    0 corresponding to "no anxious", 1 corresponding to "mildly anxious", 2 corresponding to "moderately anxious" and 3 corresponding to "very anxious"

  2. visual analogue scale

    Time frame: During radial artery cannulation (up to 1 hour)

    ranging from 0 to 10 was emplyed to assess pain intensity

  3. First-attempt success rate

    Time frame: During radial artery cannulation (up to 1 hour)

    Success at the first skin puncture

  4. Complication rate

    Time frame: postoperative 1 day and 3 day

    Hematoma, Distal ischemia, Spasm accessed by ultrasound

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiaxing University

Other

Registry information

Official study title

Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Residents: a Prospective, Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 18, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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