Anxiety, Blood Pressure
Conditions
Keywords
Dexmedetomidine, Spinal anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
DRUGDexmedetomidine with heavy bupivacaine
Dexmedetomidine infusion after IT of heavy bupivacaine
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 20 - 60 aged patients * orthopedic operation undergoing spinal anesthesia
Exclusion criteria
* more than American society of anesthesiologists classification 3 * hypertension * diabetes mellitus * heart disease (bradycardia, atrioventricular block)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypotension | up to 3 hours | We compare incidence rate of hypotension during infusion of dexmedetomidine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Anxiety | up to 3 days | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Before Spinal Anesthesia IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine | 31 |
| After Spinal Anesthesia IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine
Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Before Spinal Anesthesia | After Spinal Anesthesia | Total |
|---|---|---|---|
| Age, Continuous | 38.74 years STANDARD_DEVIATION 12.27 | 35.87 years STANDARD_DEVIATION 11.22 | 37.31 years STANDARD_DEVIATION 11.75 |
| Sex: Female, Male Female | 16 Participants | 9 Participants | 25 Participants |
| Sex: Female, Male Male | 15 Participants | 22 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Incidence of Hypotension
We compare incidence rate of hypotension during infusion of dexmedetomidine
Time frame: up to 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Before Spinal Anesthesia | Incidence of Hypotension | 15 participants |
| After Spinal Anesthesia | Incidence of Hypotension | 5 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.
Time frame: up to 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Before Spinal Anesthesia | Patient's Anxiety | State Anxiety Inventory (Preoperative) | 43.65 points | Standard Deviation 14.24 |
| Before Spinal Anesthesia | Patient's Anxiety | State Anxiety Inventory (discharge from PACU) | 37.03 points | Standard Deviation 10.51 |
| Before Spinal Anesthesia | Patient's Anxiety | State Anxiety Inventory (postoperative first day) | 34.90 points | Standard Deviation 9.03 |
| After Spinal Anesthesia | Patient's Anxiety | State Anxiety Inventory (Preoperative) | 45.52 points | Standard Deviation 12.01 |
| After Spinal Anesthesia | Patient's Anxiety | State Anxiety Inventory (discharge from PACU) | 38.55 points | Standard Deviation 8.04 |
| After Spinal Anesthesia | Patient's Anxiety | State Anxiety Inventory (postoperative first day) | 34.55 points | Standard Deviation 8.64 |