The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Administrations

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

August 15, 2025

Study Completion Date

September 1, 2025

Conditions
Spinal Anesthesia Evaluation
Interventions
DRUG

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."

DRUG

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"

Trial Locations (1)

11551

King Abdulaziz Medical City, Riyadh

All Listed Sponsors
lead

King Abdulaziz Medical City

OTHER_GOV