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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sedation and Analgesia

Intervention / Treatment
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* Drug: mild sedation and analgesia
* Drug: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mild sedation and analgesia<br>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<br>* Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation<br>* Other names: sufentanil and midazolam;|
| Active Comparator: control<br>Intravenous injection of an equivalent volume of saline before radial artery cannulation. | Drug: control<br>* ntravenous injection of an equivalent volume of saline before radial artery cannulation.<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial Artery Cannulation, Novice Operators