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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05863455
Enrollment
108
Registered
2023-05-18
Start date
2023-05-17
Completion date
2024-10-15
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation and Analgesia

Keywords

Radial Artery Cannulation, Novice Operators

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

Interventions

DRUGmild sedation and analgesia

Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation

DRUGcontrol

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

Sponsors

Affiliated Hospital of Jiaxing University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
patients discomfortDuring 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 scaleDuring radial artery cannulation (up to 1 hour)ranging from 0 to 10 was emplyed to assess pain intensity
First-attempt success rateDuring radial artery cannulation (up to 1 hour)Success at the first skin puncture
Complication ratepostoperative 1 day and 3 dayHematoma, Distal ischemia, Spasm accessed by ultrasound

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026