This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal anesthesia prolongation time in minutes, time of regression from Bromage score 3 to 0.
Male and female patients in adult age group more than 18 years old
ASA classification I, II, and III.
Orthopedic surgery, including total hip replacement (THR) and total knee replacement (TKR).
No history of Obstructive sleep apnea
Patient below 18 years old of both genders.
ASA classification of IV and more.
Patients with a height of less than 150 cm.
Patients on alpha-two antagonist ACE inhibitors and CCB.
Parallel
Interventional group#1
DrugThe 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
DrugThe 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
Regression time of Bromage score from 3 to 0
This double-blind study will include 75 participants divided equally into three groups: A, B, and C. The IT medication injection / IV infusion start time is considered time zero. The Bromage score will be assessed at the motor block's onset, representing a Bromage score of 3, recorded in minutes. The record of the time to reach Bromage 3 represents the spinal anesthesia's onset time. The Bromage scale is a clinical scale used to determine motor block during regional anesthesia. It evaluates lower limb movement, grade 0, no motor block, to grade 3, complete motor block. Bromage 0; the patient can move hip, knee, and ankle. No motor block Bromage 1: the patient cannot move the hip but can move the knee and ankle. Partial block Bromage 2: the patient cannot move the hip and knee but can move the ankle. partial block Bromage 3: the patient cannot move the hip, knee, and ankle. Complete motor block A Bronage score regression to 0 during a PACU stay will represent a spinal anesthesia offset
Hypotension, bradycardia and desaturation with dermatome coverage <T4 or >T4, checked by Ice test.
Investigators will monitor the side effects associated with each route of administration through close hemodynamic monitoring for heart rate (HR) in Beat per minute (BPM), Oxygen saturation (SpO2) presented in percentage (%), and blood pressure (BP) presented in millimeter mercury (mmHg), aiming for HR above 50 bpm, oxygen saturation \>94%, and BP 15% around the patient's baseline blood pressure. All data will be recorded on the data collection sheet. To differentiate high spinal-related hemodynamic instability ( dermatome \>4) versus dexmedetomidine (dermatome less than T4), the sensory block level will be checked with an ICE test, where the dermatomal coverage will be checked along the midaxillary line with an ice bag, as nipple line is representing dermatome T4. HR limits: 60 to 100 bpm. Lower bradycardia, higher tachycardia. BP limits, systolic 100 - 120 mmHg. Lower hypotension, higher hypertension. SpO2 limit: 100-94%, 100% standard, \<94% desaturation.
Sedation score using Ramsay sedation score, aiming for score 2; calm and oriented.
The Investigators will check the Ramsay Sedation Scale (RSS) throughout the procedure. It is used to evaluate the depth of sedation in patients and divided into six scales (from scale no.1, anxious to scale no.6, no response), aiming for scale no.2: cooperative, oriented, and calm. All data will be recorded on the data collection sheet every 10 minutes for the first hour of "Dexmedetomidine" administration and 45 minutes in PACU. The scale is getting worse while the moving up in the scale Score 1: anxious, agitated, and restless. Score 2: Cooperative-oriented and tranquil. Score 3: The patient responds to commands only. Score 4: The patient responds to a brisk response to a light glabellar tap or loud auditory stimulation. Score 5: Patient sluggishly responds to a light glabellar tap or loud auditory stimulus. Score 6: The patient exhibits no response.
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