Intrathecal Dexmedetomidine vs Midazolame
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT06315634
- Lead Sponsor
- National Cancer Institute, Egypt
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Patients undergoing lower limb orthopedic cancer surgery.
- ASA I, II, III.
- Age 20 to 70 year
- Healthy volunteers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Heavy Bupivacaine plus dexmedetomidine Dexmedetomidine 2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline Heavy Bupivacaine plus midazolam Midazolam 2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline Heavy Bupivacaine plus normal saline Bupivacain 2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline Heavy Bupivacaine plus dexmedetomidine Bupivacain 2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline Heavy Bupivacaine plus midazolam Bupivacain 2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
National cancer institute
🇪🇬Cairo, Egypt