Sedation and AnalgesiaNCT05863455
Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Residents
A study testing mild sedation and analgesia in people with Sedation and Analgesia, run by Affiliated Hospital of Jiaxing University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sedation and Analgesia
- What is being tested?
- mild sedation and analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
outcome: patients discomfort，visual analogue scale，First-attempt success rate，the success rate of radial artery cannulation within 10 minutes, Complication rate
- Conditions
- Sedation and Analgesia
- Being tested
- mild sedation and analgesia, control
- Keywords
- Radial Artery Cannulation, Novice Operators
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild sedation and analgesiaDrug
Also called sufentanil and midazolam
Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation
controlDrug
Also called saline
ntravenous injection of an equivalent volume of saline before radial artery cannulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: mild sedation and analgesia |
| control | Active comparator | Intravenous injection of an equivalent volume of saline before radial artery cannulation. Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate
success rate of puncture and catheter placement within 10 minutes.
Measured: During radial artery cannulation (up to 1 hour)
Secondary outcomes (4)
patients discomfort
0 corresponding to "no anxious", 1 corresponding to "mildly anxious", 2 corresponding to "moderately anxious" and 3 corresponding to "very anxious"
Measured: During radial artery cannulation (up to 1 hour)
visual analogue scale
ranging from 0 to 10 was emplyed to assess pain intensity
Measured: During radial artery cannulation (up to 1 hour)
First-attempt success rate
Success at the first skin puncture
Measured: During radial artery cannulation (up to 1 hour)
Complication rate
Hematoma, Distal ischemia, Spasm accessed by ultrasound
Measured: postoperative 1 day and 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start17 May 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedation and AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- Qinghe Zhou, Principal investigator, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863455
- Sponsor's protocol ID
- 2023-KY-297
- Status last verified
- Nov 2024
- First submitted
- 8 May 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39709419
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Residents: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05863455
- Acronym / sponsor ID
- 2023-KY-297
- Conditions
- Sedation and Analgesia
- Keywords
- Radial Artery Cannulation, Novice Operators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild sedation and analgesia | Experimental | Drug: mild sedation and analgesiaIntravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation. |
| control | Active comparator | Drug: controlIntravenous injection of an equivalent volume of saline before radial artery cannulation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mild sedation and analgesiaAlso: sufentanil and midazolamIntravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation | Drug | mild sedation and analgesia |
| controlAlso: salinentravenous injection of an equivalent volume of saline before radial artery cannulation. | Drug | control |
Primary outcome
Overall success rate
Time frame: During radial artery cannulation (up to 1 hour)
success rate of puncture and catheter placement within 10 minutes.
4 secondary outcomes
patients discomfort
Time frame: During radial artery cannulation (up to 1 hour)
visual analogue scale
Time frame: During radial artery cannulation (up to 1 hour)
First-attempt success rate
Time frame: During radial artery cannulation (up to 1 hour)
Complication rate
Time frame: postoperative 1 day and 3 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 39709419Xi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinghe Zhou principal investigator
Affiliated Hospital of Jiaxing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mild sedation and analgesia in people with Sedation and Analgesia, run by Affiliated Hospital of Jiaxing University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall success rate (time frame: During radial artery cannulation (up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.