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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine-ketamine | Experimental | Dexmedetomidine-ketamine group |
|
| Dexmedetomidine-fentanyl | Active Comparator | Dexmedetomidine-fentanyl group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | dexmedetomidine infusion during spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score Using Five Scales | We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia. | average 10-20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Patient Positioning | We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups. | average 10-20 minutes during spinal anesthesia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Eun Lee, MD | Inje University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haeundae paik hospital, inje university | Busan | 612-896 | South Korea |
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from May 2014 to October 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine-ketamine | Dexmedetomidine-ketamine group Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia Ketamine: add dexmedetomidine during position change |
| FG001 | Dexmedetomidine-fentanyl | Dexmedetomidine-fentanyl group Dexmedetomidine: dexmedetomidine infusion during spinal anesthesia Fentanyl: add dexmedetomidine during position change |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine-Ketamine | Dexmedetomidine-Ketamine combination |
| BG001 | Dexmedetomidine-Fentanyl | Dexmedetomidine-Fentanyl combination |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score Using Five Scales | We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia. | Posted | Count of Participants | Participants | average 10-20 minutes |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine-Ketamine | Dexmedetomidine-Ketamine combination | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative cardiopulmonary resuscitation | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ki Hwa Lee | Inje University, Haeundae paik hospital | 82-51-797-0421 | tedy3333@naver.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2019 | Apr 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl | Drug | add dexmedetomidine during position change |
|
|
| Ketamine | Drug | add dexmedetomidine during position change |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Quality of Patient Positioning | We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups. | Posted | Count of Participants | Participants | average 10-20 minutes during spinal anesthesia |
|
|
|
| 22 |
| 0 |
| 22 |
| 21 |
| 22 |
| EG001 | Dexmedetomidine-Fentanyl | Dexmedetomidine-Fentanyl combination | 1 | 21 | 1 | 21 | 20 | 21 |
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D010880 |
| Piperidines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| 2 |
|
| 3 |
|
| 4 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 2 |
|
| 3 |
|
| Hip flexion |
|
| Spinal block |
|