Regular bupivacaine dosages are linked to considerable sympathetic block, as well as persistent and severe sensory and motor block, which may not be desired for certain individuals. Although diluted bupivacaine at low doses restricts the distribution of spinal block and produces a comparatively quick recovery, it might not offer a sufficient degree of sensory block.Bupivacaine's side effects and dosage requirements are lessened by the potentiating effects of the short-acting lipophilic opioid fentanyl and the more selective α2 agonist dexmedetomidine. These spinal adjuncts are used to extend analgesia in addition to lessening the negative effects of local anesthetics. According to a number of studies, when given intrathecally, α2 receptor agonists will increase the analgesia that subtherapeutic doses of local anesthetics like bupivacaine deliver because of their synergistic effects with little hemodynamic effects.The goal will be to determine if bupivacaine and fentanyl or bupivacaine and dexmedetomidine produced higher-quality anesthesia.
Spinal anesthesia is a straightforward procedure that acts quickly. However, because of its neurotoxic effects, a common anesthetic like lidocaine has mostly been substituted by alternative substances like bupivacaine. Regular bupivacaine dosages are linked to considerable sympathetic block, as well as persistent and severe sensory and motor block, which may not be desired for certain individuals. Although diluted bupivacaine at low doses restricts the distribution of spinal block and produces a comparatively quick recovery, it might not offer a sufficient degree of sensory block. Bupivacaine's side effects and dosage requirements are lessened by the potentiating effects of the short-acting lipophilic opioid fentanyl and the more selective α2 agonist dexmedetomidine. These spinal adjuncts are used to extend analgesia in addition to lessening the negative effects of local anesthetics. The danger of respiratory depression for lipophilic opioids, such as fentanyl and sufentanil, is primarily restricted to the first two hours following intrathecal injection. Because fentanyl is more lipid soluble than morphine, there is a significantly lower chance of delayed respiratory depression brought on by the rostral distribution of an intrathecal injected drug to respiratory centers. Both visceral and somatic pain can be reduced by intrathecal α2 receptor agonists. Compared to clonidine (α2/α1 200:1), dexmedetomidine has greater selectivity for the α2 receptor (α2/α1 1600:1). According to a number of studies, when given intrathecally, α2 receptor agonists will increase the analgesia that subtherapeutic doses of local anesthetics like bupivacaine deliver because of their synergistic effects with little hemodynamic effects. The goal will be to determine if bupivacaine and fentanyl or bupivacaine and dexmedetomidine produced higher-quality anesthesia. . Methods and patients: After obtaining Institutional Ethical Committee approval, this prospective randomised double-blinded study was carried out in a tertiary health care centre on 60 patients After obtaining Institutional Ethical Committee approval, this prospective randomised double-blinded study will be carried out in a tertiary health care centre on 60 patients of Intervention: Spinal anaesthesia will be performed in all patients in the sitting position. Under strict aseptic precautions, using 25G Quincke needle mid-line spinal puncture was performed at L2-L3 level. In Group fentanyl (F), an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) was administered intrathecally. In Group dexmedetomidine( D), dexmedetomidine will be first diluted in normal saline to obtain a dose of 5 μg in 0.5 ml. Then, an injection of bupivacaine 0.5% (3.5 ml) + dexmedetomidine 0.5 ml (5 μg) will be administered intrathecally. Drug will be administered over 10 seconds (s) using 5 cc syringes with cephalad orientation of the spinal needle bevel. The patients were turned supine immediately after the injection of the drug. Midazolame and fentanyle will be administered on request as rescue analgesic and for sedation if needed . post-operatively and side-effects such as hypotension, bradycardia, pruritus, vomiting, shivering, respiratory depression were also monitored. Pruritus was managed with i.v chlorpheniramine maleate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Group fentanyl (F), an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be administered intrathecally.
Group dexmedetomidine( D), dexmedetomidine will be first diluted in normal saline to obtain a dose of 5 μg in 0.5 ml. Then, an injection of bupivacaine 0.5% (3.5 ml) + dexmedetomidine 0.5 ml (5 μg) will be administered intrathecally. Drug will be administered over 10 seconds (s) using 5 cc syringes with cephalad orientation of the spinal needle bevel.
Faculty of medicine ,Alexandria university
Alexandria, Alexandria Governorate, Egypt
to evaluate patient satisfaction
The level of patient's satisfaction was measured using five-point Likert scale ((1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)
Time frame: at the end of the surgery (assessed up to 40 minutes)
to evaluate the sedation grade
5- Ramsay Sedation Score 1. \- Anxious, agitated/restless or both 2. \- Patient cooperative, oriented, and tranquil 3. \- Patient responds to commands only 4. \- Brisk response to a light glabellar tap or loud auditory stimulus 5. \- Sluggish response to light glabellar tap or loud auditory stimulus 6. \- Patient shows no response.
Time frame: 10 minutes after giving the intervention , then after 30 minutes , then at the end of the surgery (assessed up to 40 minutes)
to compare analgesia onset, duration ,peak sensory level
Sensory block level which will be defined as the loss of pain sensation to pin prick test in the midclavicular line, will be measured every1 min until it reached T6 level, and the surgeons will be asked to start. And record the time to reach peak sensory level .
Time frame: after giving the intervention every 1 minutes till reach level T6 (assessed up to 10 minutes)
to compare the initial post-operative analgesia request
recording the time the patient need rescue analgesia post operative
Time frame: 24 hour after surgery
to compare the onset,duration of motor blockade between the two groups
Motor block of lower limbs was assessed bilaterally using a modified Bromage scale as 0=no paralysis, 1=cannot raise extended leg, 2=cannot flex the knee, and 3=cannot dorsiflex the ankle.
Time frame: Motor power assessment was done every five minutes, for 30 min after spinal anesthesia, and then every 20 min until the end of surgery. The time to achieve Bromage 3 was considered an onset of the motor block. Duration of motor block was considered until
to compare the mean arterial blood pressure between the two groups
Mean blood pressure will be recorded every 5 min up to 15 min and then every 15 min during surgery then for each hour after surgery in the ward (up to 4 hour) . Hypotension, defined as mean BP less than 60 mm Hg will be treated by injection of ephedrine and crystalloids intravenous .
Time frame: every 5 min up to 15 min after the intervention , then every 15 min during surgery and then for each hour after surgery in the ward(up to 4 hour).
to record Post-operative and intraoperative complications
Post-operative and intraoperative complications (respiratory depression, hypotension, bradaycardia,shivering ,vomiting ,nausea,pruitis)
Time frame: during the procedure ,24 hour postoperatively
to compare heart rate between to groups
Heart rate (HR) will be recorded every 5 min up to 15 min and then every 15 min during surgery then for each hour after surgery in the ward. Bradycardia was defined as HR \<60 beats/min will be treated with intravenous atropine 0.3 mg increments.
Time frame: every 5 min up to 15 min after the intervention , then every 15 min during surgery and then for each hour after surgery in the ward(up to 4 hour)
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