Knee Surgery, Pelvic Surgery, Spinal Aneshtesia
Conditions
Brief summary
Determine ED50 dexmedetomidine adjuvant that can provide spinal anesthetic sensory blockade duration of 200 minutes on knee and pelvis surgery with up-and-down method.
Interventions
DRUGDexmedetomidine 3 mcg
Patient received spinal injection of dexmedetomidine 3 mcg.
DRUGDexmedetomidine 4 mcg
Patient received spinal injection of dexmedetomidine 4 mcg.
Patient received spinal injection of dexmedetomidine 5 mcg.
DRUGDexmedetomidine 6 mcg
Patient received spinal injection of dexmedetomidine 6 mcg.
DRUGBupivacain hyperbaric 0.5% 12.5 mg
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg
Sponsors
Indonesia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-60 years old * Pelvic or knee surgery patient with American Society of Anesthesiologists physical status I - III with epidural spinal anesthesia * Body mass index 18-35 kg/m2 * Body height 150-180 cm * Willing to become a research participant
Exclusion criteria
* Have a history of allergy to bupivacaine or dexmedetomidine * Have sensory or motoric disabilities in the lower extremity contralateral to the surgery area * Have a history of congestive heart failure and/or heart rhythm disorder * Have regional anesthesia contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Effective Sensory Blockade (≥200 Minutes) | Until the end of the surgery | Effectiveness is defined as a sensory blockade duration of at least 200 minutes from administration of spinal anesthesia with adjuvant dexmedetomidine to regression of sensory level to the T12 dermatome. Participants with blockade duration \<200 minutes will be considered not effective. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension Incidence | At the start of surgery until the end of surgery | Whether the patient experienced drop in blood pressure (systolic, diastolic, and mean arterial pressure) \> 20% from base value. |
| Bradycardia Incidence | Until the end of surgery | Whether patient experienced drop in heart rate to \<50 beat per minute. |
| Nausea Incidence | Until the end of surgery | Whether patient experienced persistent nausea that cause vomiting. |
Countries
Indonesia
Outcome results
None listed