Percutaneous Nephrolithotomy (PCNL)
Conditions
Keywords
percutaneous nephrolithotomy, intrathecal additive, dexametamodine, fentanyl
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREIntrathecal Fentanyl Group (F)
Group fentanyl (F), an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be administered intrathecally.
PROCEDUREintrathecal dexmedetomidine group(D)
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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A randomized superiority trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* both sex aged between 18 and 60 years, * belonging to American Society of Anaesthesiologists (ASA) physical status Grade I and II undergoing PCNL under spinal anaesthesia.
Exclusion criteria
* Patients with a history of spine surgery, * infection at the injection site, * coagulopathy, * hypovolemia, * increased intracranial pressure, * indeterminate neurologic disease, * spinal deformities, * communication problems, * known hypersensitivity to local anaesthetics, opioids or dexmedetomidine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate patient satisfaction | at the end of the surgery (assessed up to 40 minutes) | 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) |
| to evaluate the sedation grade | 10 minutes after giving the intervention , then after 30 minutes , then at the end of the surgery (assessed up to 40 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to compare analgesia onset, duration ,peak sensory level | after giving the intervention every 1 minutes till reach level T6 (assessed up to 10 minutes) | 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 . |
| to compare the initial post-operative analgesia request | 24 hour after surgery | recording the time the patient need rescue analgesia post operative |
| to compare the onset,duration of motor blockade between the two groups | 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 | 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. |
| to compare the mean arterial blood pressure between the two groups | 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). | 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 . |
| to record Post-operative and intraoperative complications | during the procedure ,24 hour postoperatively | Post-operative and intraoperative complications (respiratory depression, hypotension, bradaycardia,shivering ,vomiting ,nausea,pruitis) |
| to compare heart rate between to groups | 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) | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORIslam Elbardan, Dr
University of Alexandria
Outcome results
None listed