Back to resultsThe Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Operators
Primary Purpose
Sedation and Analgesia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mild sedation and analgesia
control
Sponsored by
About this trial
This is an interventional treatment trial for Sedation and Analgesia focused on measuring Radial Artery Cannulation, Novice Operators
Eligibility Criteria
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.
Sites / Locations
- Affiliated Hospital of Jiaxing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mild sedation and analgesia
control
Arm Description
Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation.
Intravenous injection of an equivalent volume of saline before radial artery cannulation.
Outcomes
Primary Outcome Measures
First-attempt success rate
Success at the first skin puncture
Secondary Outcome Measures
Overall attempt
Number of attempt of radial artery cannulation
Overall Procedure time
From ultrasound guidance, to Arterial waveform
Overall success rate
success rate of puncture and catheter placement within 5 minutes.
Complication rate
Hematoma, Distal ischemia, Spasm accessed by ultrasound
Full Information
NCT ID
NCT05863455
First Posted
May 8, 2023
Last Updated
May 22, 2023
Sponsor
Affiliated Hospital of Jiaxing University
1. Study Identification
Unique Protocol Identification Number
NCT05863455
Brief Title
The Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Operators
Official Title
The Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Operators
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiaxing University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation and Analgesia
Keywords
Radial Artery Cannulation, Novice Operators
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mild sedation and analgesia
Arm Type
Experimental
Arm Description
Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation.
Arm Title
control
Arm Type
Active Comparator
Arm Description
Intravenous injection of an equivalent volume of saline before radial artery cannulation.
Intervention Type
Drug
Intervention Name(s)
mild sedation and analgesia
Other Intervention Name(s)
sufentanil and midazolam
Intervention Description
Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation
Intervention Type
Drug
Intervention Name(s)
control
Other Intervention Name(s)
saline
Intervention Description
ntravenous injection of an equivalent volume of saline before radial artery cannulation.
Primary Outcome Measure Information:
Title
First-attempt success rate
Description
Success at the first skin puncture
Time Frame
During radial artery cannulation (up to 1 hour)
Secondary Outcome Measure Information:
Title
Overall attempt
Description
Number of attempt of radial artery cannulation
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Overall Procedure time
Description
From ultrasound guidance, to Arterial waveform
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Overall success rate
Description
success rate of puncture and catheter placement within 5 minutes.
Time Frame
During radial artery cannulation (up to 1 hour)
Title
Complication rate
Description
Hematoma, Distal ischemia, Spasm accessed by ultrasound
Time Frame
After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinghe Zhou
Phone
+8613732573379
Email
jxxmxy@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yazhi Xi
Phone
+8615536368031
Email
xiyazhi1996@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinghe Zhou
Organizational Affiliation
Affiliated Hospital of Jiaxing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Jiaxing University
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghe Zhou
Phone
+8613732573379
Email
jxxmxy@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Operators
We'll reach out to this number within 24 hrs