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Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively.
The investigators will compare of hemodynamics and patient's comfortability between two groups.
A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine |
|
| Dexmedetomidine with heavy bupivacaine | Active Comparator | IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypotension | We compare incidence rate of hypotension during infusion of dexmedetomidine | up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Anxiety | We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Hwa Lee, MD | Inje University Haeundae Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University, Haeundae paik hospital | Busan | 612-896 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27871236 | Derived | Kang E, Lee KH, Jeon SY, Lee KW, Ko MJ, Kim H, Kim YH, Jung JW. The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial. BMC Anesthesiol. 2016 Nov 21;16(1):116. doi: 10.1186/s12871-016-0282-2. |
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De-identified individual participant data for all primary and secondary outcome measures will be made available within 3 years of study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine Before Bupivacaine | IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine |
| FG001 | Dexmedetomidine After Bupivacaine | IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Before Spinal Anesthesia | IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine |
| BG001 | After Spinal Anesthesia |
| 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 | Incidence of Hypotension | We compare incidence rate of hypotension during infusion of dexmedetomidine | Posted | Number | participants | up to 3 hours |
|
<24 hours
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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 | Before Spinal Anesthesia | IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine |
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We did not assess the differences among the groups regarding postoperative analgesic consumption and the duration of sensory or motor bloakade produced by spinal anesthesia with dexmedetomidine infusion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ki Hwa Lee | Haeundae paik hospital, Inje University | 82-51-797-0421 | tedy3333@naver.com |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexmedetomidine with heavy bupivacaine | Drug | Dexmedetomidine infusion after IT of heavy bupivacaine |
|
|
| up to 3 days |
IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Patient's Anxiety | We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery. | Posted | Mean | Standard Deviation | points | up to 3 days |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | After Spinal Anesthesia | IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine | 0 | 37 | 0 | 37 |
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| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| State Anxiety Inventory (postoperative first day) |
|