75
Participants
Start Date
March 1, 2025
Primary Completion Date
August 15, 2025
Study Completion Date
September 1, 2025
Interventional group#1
"The intrathecal mixture of spinal anesthesia: 12 mg of isobaric Bupivacaine 0.5%, Bucaine®, (2.4 ml) + 20 mcg of Fentanyl, Martindale pharma Fentanyl®, 50mcg/ml (0.4ml) + 3 mcg of Dexmedetomidine HCL, Demexa®, 4mcg/ml (0.75 ml) total volume = 3.55 ml.~The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision. The Bromage score is a clinical scale used to determine motor block during regional anesthesia by evaluating lower limb movement: Grade 0: Full movement of hips, knees, and ankles (no block). Grade 1: Unable to lift the leg but can move knees and ankles (partial block). Grade 2: Unable to bend the knee but can move ankles (near-complete block). Grade 3: No movement in hips, knees, or ankles (complete block). Dermatomal coverage will be assessed simultaneously till it reaches the L1-L2 level. Also, The Ramsay Sedation Scale (RSS) will be used to evaluate the sedation depth, if any."
Interventional group#2
"The intrathecal mixture of spinal anesthesia: 12 mg of isobaric Bupivacaine 0.5%, Bucaine®, (2.4 ml) + 20 mcg of Fentanyl, Martindale pharma Fentanyl®, 50mcg/ml (0.4ml) total volume = 2.8 ml.~The intravascular mixture consists of 0.5 mcg/kg of Dexmedetomidine HCL, Demexa®, and a maximum of 30 mcg diluted to 4 mcg/ml. According to body weight, the total volume is 7.5 ml or less and given using a syringe pump over 30 minutes. The anesthesiologist will start the infusion once the patient is positioned supine post-spinal anesthesia and has stable hemodynamics. The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision reaches grade 3: No movement in hips, knees, or ankles (complete block). The anesthesiologist will assess dermatomal coverage until it reaches the L1-L2 and calculate the Ramsay Sedation Scale (RSS) of the depth of sedation aiming for level 2: Patient is cooperative, oriented, and calm"
King Abdulaziz Medical City, Riyadh
King Abdulaziz Medical City
OTHER_GOV