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

Not Applicable

Completed

• Conditions: Sedation and Analgesia
• Interventions: Drug: control; Drug: mild sedation and analgesia

• Registration Number: NCT05863455
• Lead Sponsor: Affiliated Hospital of Jiaxing University

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-16
• Study Start: 2023-05-17
• Study First Posted: 2023-05-18
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-30
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	Intravenous injection of an equivalent volume of saline before radial artery cannulation.
mild sedation and analgesia	mild sedation and analgesia	Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation.

Primary Outcome Measures

Name	Time	Method
Overall success rate	During radial artery cannulation (up to 1 hour)	success rate of puncture and catheter placement within 10 minutes.

Secondary Outcome Measures

Name	Time	Method
patients discomfort	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"
visual analogue scale	During radial artery cannulation (up to 1 hour)	ranging from 0 to 10 was emplyed to assess pain intensity
First-attempt success rate	During radial artery cannulation (up to 1 hour)	Success at the first skin puncture
Complication rate	postoperative 1 day and 3 day	Hematoma, Distal ischemia, Spasm accessed by ultrasound

Trial Locations

Locations (1)

Affiliated Hospital of Jiaxing University; 🇨🇳 Jiaxing, Zhejiang, China