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出境医 / 临床实验 / The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter
The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter
Study Description
Brief Summary:
Compare the effect of periradial injection of papaverine versus nitroglycerine on radial artery diamter before cannulation of it in cardiac surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Radial Artery Injury Prevetion | Drug: papaverine Drug: nitroglycerine Drug: xlyocaine | Early Phase 1 |
Detailed Description:
we want in this study to facilitate radial artery canulation and decrease the number of attemps of puncture which may lead to disappearance of the pulse.
The aim of this study is to compare the effect of adding papaverine to local anesthetic xylocaine versus adding nitroglycerine to it on the diameter and palpability of radial artery and if perioperative spasm will decrease significantly with one of these methods.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter Prior to Cannulation. |
| Actual Study Start Date : | February 5, 2019 |
| Actual Primary Completion Date : | September 1, 2019 |
| Actual Study Completion Date : | September 2, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: papaverine |
Drug: papaverine
periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
|
| Active Comparator: nitroglycerine |
Drug: nitroglycerine
periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
|
| Placebo Comparator: xlyocaine |
Drug: xlyocaine
periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
|
Outcome Measures
Primary Outcome Measures :
- diameter of radial artery [ Time Frame: 20 minutes ]after periradial injection of one of the drugs we will feel the radial artery pulse and record if there is a change in the palpatory score and mesure the diameter of the radial artery by ultrasound in cardiac surgery patients
Secondary Outcome Measures :
- spasm of radial artery [ Time Frame: 24 hours ]detect if there is postoperative spasm of radial artery
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who will be included in the study are those scheduled for elective cardiac surgery who are hemodynamically stable.
Exclusion Criteria:
- Any patient with negative modified Allen test, atrioventricular block, glaucoma, altered liver function, unstable hemodynamics, emergency surgeries, and peripheral vascular disease.
Contacts and Locations
Locations
| Egypt | |
| Faculty of Medicine | |
| Cairo, Benisuef, Egypt, 28735 | |
Sponsors and Collaborators
Kasr El Aini Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 21, 2019 | ||||
| First Posted Date ICMJE | July 24, 2019 | ||||
| Last Update Posted Date | September 16, 2020 | ||||
| Actual Study Start Date ICMJE | February 5, 2019 | ||||
| Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
diameter of radial artery [ Time Frame: 20 minutes ] after periradial injection of one of the drugs we will feel the radial artery pulse and record if there is a change in the palpatory score and mesure the diameter of the radial artery by ultrasound in cardiac surgery patients
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
spasm of radial artery [ Time Frame: 24 hours ] detect if there is postoperative spasm of radial artery
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter | ||||
| Official Title ICMJE | The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter Prior to Cannulation. | ||||
| Brief Summary | Compare the effect of periradial injection of papaverine versus nitroglycerine on radial artery diamter before cannulation of it in cardiac surgery. | ||||
| Detailed Description |
we want in this study to facilitate radial artery canulation and decrease the number of attemps of puncture which may lead to disappearance of the pulse. The aim of this study is to compare the effect of adding papaverine to local anesthetic xylocaine versus adding nitroglycerine to it on the diameter and palpability of radial artery and if perioperative spasm will decrease significantly with one of these methods. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Early Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE | Radial Artery Injury Prevetion | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
90 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | September 2, 2019 | ||||
| Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: - Patients who will be included in the study are those scheduled for elective cardiac surgery who are hemodynamically stable. Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04030663 | ||||
| Other Study ID Numbers ICMJE | FWA00015574 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | ahmed said, Kasr El Aini Hospital | ||||
| Study Sponsor ICMJE | Kasr El Aini Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Kasr El Aini Hospital | ||||
| Verification Date | September 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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