Postoperative Pain
Conditions
Brief summary
Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Detailed description
Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients
Interventions
DRUGDexmedetomidine
5 micrograms intrathecal dexmedetomidine
DRUGMidazolam
2 milligrams intrathecal midazolam
DRUGBupivacain
12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing lower limb orthopedic cancer surgery. * ASA I, II, III. * Age 20 to 70 year * Healthy volunteers
Exclusion criteria
* Age less than 20 and older than 70. * ASA IV, V. * patients' refusal. * patients with coagulopathy. * patients with severe valvular stenosis * patients with infection at site of injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of sensory block | 12 hours | Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of vomiting occurrence | 12 hours | The patient will be reported in case of vomiting occurrence |
| Sedation | 12 hours | Ramsay's sedation score1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to pain |
| Change in mean arterial blood pressure | 12 hours | Non invasive blood pressure measurement |
| Duration of motor block | 12 hours | Ability of patient to regain full motor power |
| Change in heart rate | 12 hours | Heart rate will be compared between the three groups and will be compared with baseline preoperative values in each group |
Countries
Egypt
Outcome results
None listed