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

Sedation and Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863455
• Other study ID #: 2023-KY-297
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Affiliated Hospital of Jiaxing University
• Contact: Qinghe Zhou
• Phone: +8613732573379
• Email: jxxmxy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sedation and Analgesia

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiaxing University	Jiaxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First-attempt success rate	Success at the first skin puncture	During radial artery cannulation (up to 1 hour)
Secondary	Overall attempt	Number of attempt of radial artery cannulation	During radial artery cannulation (up to 1 hour)
Secondary	Overall Procedure time	From ultrasound guidance, to Arterial waveform	During radial artery cannulation (up to 1 hour)
Secondary	Overall success rate	success rate of puncture and catheter placement within 5 minutes.	During radial artery cannulation (up to 1 hour)
Secondary	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)