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

NCT05863455 | Completed

• 1 other identifier: 2023-KY-297
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation and Analgesia

Keywords

Radial Artery Cannulation; Novice Operators

Outcome Measures

Primary Outcomes (1)

• Overall success rate

  success rate of puncture and catheter placement within 10 minutes.

  During radial artery cannulation (up to 1 hour)

Secondary Outcomes (4)

• patients discomfort

  During radial artery cannulation (up to 1 hour)

• visual analogue scale

  During radial artery cannulation (up to 1 hour)

• First-attempt success rate

  During radial artery cannulation (up to 1 hour)

• Complication rate

  postoperative 1 day and 3 day

Study Arms (2)

mild sedation and analgesia

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

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

Drug: control

Interventions

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

Also known as: sufentanil and midazolam

mild sedation and analgesia

control DRUG

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

Also known as: saline

control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

Location

Related Publications (1)

• Xi YZ, Li ZP, Zhou QH. Effect of mild sedation and analgesia on radial artery cannulation in novice residents: a prospective, randomized controlled trial. BMC Med Educ. 2024 Dec 21;24(1):1515. doi: 10.1186/s12909-024-06568-8.

  PMID: 39709419 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia; Sufentanil; Midazolam; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Qinghe Zhou

  Affiliated Hospital of Jiaxing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 18, 2023
• Study Start: May 17, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)