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

NCT ID: NCT05863455

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2024-10-15

Brief Summary

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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

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

Conditions

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Sedation and Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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mild sedation and analgesia

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

Group Type EXPERIMENTAL

mild sedation and analgesia

Intervention Type DRUG

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

control

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

Group Type ACTIVE_COMPARATOR

control

Intervention Type DRUG

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

Interventions

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mild sedation and analgesia

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

Intervention Type DRUG

control

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

Intervention Type DRUG

Other Intervention Names

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sufentanil and midazolam saline

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role lead

Responsible Party

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Qing-he Zhou

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qinghe Zhou

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiaxing University

Locations

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Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39709419 (View on PubMed)

Other Identifiers

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2023-KY-297

Identifier Type: -

Identifier Source: org_study_id