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

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

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: Completed
• Conditions: Sedation and Analgesia
• Intervention / Treatment: Drug: mild sedation and analgesia; Drug: control

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jiaxing, Zhejiang, China, 314000
      • Affiliated Hospital of Jiaxing University

Participation Criteria

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
• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

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

Secondary 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)
patients discomfort	0 corresponding to "no anxious", 1 corresponding to "mildly anxious", 2 corresponding to "moderately anxious" and 3 corresponding to "very anxious"	During radial artery cannulation (up to 1 hour)
visual analogue scale	ranging from 0 to 10 was emplyed to assess pain intensity	During radial artery cannulation (up to 1 hour)
Complication rate	Hematoma, Distal ischemia, Spasm accessed by ultrasound	postoperative 1 day and 3 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 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 (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Radial Artery Cannulation; Novice Operators
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Midazolam; Sufentanil
• 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