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Dexmedetomidine versus fentanyl added to bupivacaine for epidural analgesia in combination with general anesthesia for elective lumbar disc operations: A prospective, randomized double-blinded study.

ABSTRACT: Background:The literature on drugs used for combined general anesthesia and epidural analgesia (CGE) in lumbar operations is scarce. The purpose of the study was to compare the addition of either dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia with regard to efficacy and adverse events in such operations. Materials and Methods:This prospective, randomized, double-blinded study was conducted on 80 patients who were scheduled for an elective lumbar disc operation, age 20-65 years, of either sex and American Society of Anesthesiologists physical status I or II. They were randomly allocated into one of the two groups - group bupivacaine-dexmedetomidine (BD) (n = 40): patients who received CGE with 15 mL of bupivacaine 0.20% plus 50 ?g of dexmedetomidine and group bupivacaine-fentanyl (BF) (n = 40): patients who received CGE with 15 mL of bupivacaine 0.20% plus 50 ?g fentanyl. The primary outcome was time to first analgesic requirement, whereas the secondary outcomes were the total opioid consumption and pain scores during the first 24 h. The incidence of adverse postoperative (PO) effects related to the study drugs, such as sedation, nausea and vomiting, pruritus, shivering, and respiratory depression, was also documented. Results:Patients in the BD group experienced a significantly prolonged pain-free period, lower total opioid consumption, and lower pain scores than patients in the BF group (P < 0.001). Patients in the BD group showed a significantly lower intraoperative heart rate and mean blood pressure (P < 0.001). Regarding adverse events, there were greater PO sedation scores (P < 0.001) and less frequent episodes of PO nausea and vomiting in the BD group. In addition, patients in the BD group showed less pruritis and shivering. There were no reported cases of respiratory depression in either group. Conclusion:CGE with bupivacaine plus dexmedetomidine provided better PO pain control than bupivacaine plus fentanyl, with fewer adverse events overall.

SUBMITTER: Alansary AM

PROVIDER: S-EPMC6448444 | biostudies-literature | 2019 Apr-Jun

REPOSITORIES: biostudies-literature

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Dexmedetomidine versus fentanyl added to bupivacaine for epidural analgesia in combination with general anesthesia for elective lumbar disc operations: A prospective, randomized double-blinded study.

Alansary Amin Mohammed AM Elbeialy Marwa Ahmed Khairy MAK

Saudi journal of anaesthesia 20190401 2

<h4>Background</h4>The literature on drugs used for combined general anesthesia and epidural analgesia (CGE) in lumbar operations is scarce. The purpose of the study was to compare the addition of either dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia with regard to efficacy and adverse events in such operations.<h4>Materials and methods</h4>This prospective, randomized, double-blinded study was conducted on 80 patients who were scheduled ...[more]

PMID: 31007657

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Project description:The analgesic and sedative effect of clonidine explain its common use as adjuvant in regional anesthesia, however the hemodynamic instability associated with its neuroaxial administration is the major drawback. Our study hypothesis is to compare the hemodynamic and analgesic effect of epidural fentanyl in comparison to meperidine when added to clonidine in patients undergoing lower limbs orthopedic surgery using combined spinal-epidural anesthesia.One hundred thirty five ASA physical status I or II patients were recruited for lower limb orthopedic surgery. All received 2 mL intrathecal 0.5 % hyperbaric bupivacaine, 10 mL epidural 0.25 % plain bupivacaine, and 1 mL epidural clonidine 2 ?g/kg (Clonidine group) and then either 1 ml fentanyl 25 ?g (Fentanyl Group) or 1 ml meperidine 25 mg (Meperidine Group). The quality of surgical anesthesia, incidence of hypotension and bradycardia, intra-operative pain assessment, and onset of postoperative pain, sedation scores and side effects in the postoperative period were recorded.The 1(st) analgesic requirement in the postoperative period was significantly prolonged in the meperidine group (p = 0.001). Significant decrease in the mean arterial blood pressure in fentanyl group was at 15, 30, 45, 60 and 90 min (p = 0.035, 0.019, 0.027, 0.032 and 0.039) respectively, significant decrease in meperdine group was at 15 and 30 min (p = 0.038 and 0.043), while in clonidine group a significant decrease was at 15, 30, 45, and 60 min (p = 0.025, 0.028, 0.036 and 0.042) respectively. Among group changes, the mean arterial blood pressure was significantly higher in meperdine group at 30, 45, 60 and 90 min (p = 0.007, 0.015, 0.029 and 0.033) respectively. A significant decrease in the heart rate in fentanyl group at 15, 30 and 45 min (p = 0.035, 0.018 and 0.029), in meperdine group a significant decrease in the heart rate was at 15 min (p = 0.038), while in clonidine group a significant decrease was at 15, and 30 min (p = 0.016 and 0.003) . Among group changes, the heart rate was significantly higher in meperdine group at 30, 45 and 60 min (p = 0.021, 0.017 and 0.011). VAS were significantly lower in meperdine group in comparison to fentanyl and clonidine groups at 2 h, 3 h and 4 h post-operative period (p = 0.024, 0.001 and 0.039).The combined administration of epidural clonidine and meperidine provided better intraoperative hemodynamics and prolonged postoperative analgesia than epidural clonidine fentanyl combination in patients undergoing lower limb orthopedic surgery.Clinical Trail Registry (Clinicaltrail.gov) NCT 02128451 .

Project description:BackgroundAdministration of adjuvant drugs epidurally in combination with local anesthetics offers new dimensions in the management of postoperative pain. This study aimed to compare the addition of either nalbuphine or dexmedetomidine to epidural bupivacaine for postoperative analgesia in lower limb orthopedic surgeries under combined spinal-epidural anesthesia.MethodsThis prospective randomized double-blind study included 69 patients scheduled for lower limb orthopedic surgeries. Anesthesia was started with 15 mg hyperbaric bupivacaine 0.5% intrathecally, and then an epidural bolus dose of 12 ml (10 ml 0.25% bupivacaine with 2 ml normal saline in group C, 2 ml (10 mg) nalbuphine in group N or dexmedetomidine 2 ml (100 µg) in group D was administered when sensory regression to T10. Postoperatively, when visual analogue scale (VAS) was ≥ 3, an epidural top-up dose of 8 ml (6 ml 0.25% bupivacaine plus 2 ml normal saline in group C, 2 ml (2 mg) nalbuphine in group N or 20 µg dexmedetomidine (2 ml) in group D was given. The primary outcome was to evaluate the duration of postoperative analgesia and secondary outcomes were any side effects and patient satisfaction.ResultsThe onset of epidural analgesia was 17.83 ± 2.53 versus 13.39 ± 1.27 versus 12.17 ± 1.27 min in groups C, N and D, respectively (p value < 0.001). The mean duration of analgesia was 241.3 ± 14.24 versus 318.38 ± 22.54 versus 365.87 ± 18.01 min in groups C, N and D, respectively (p value < 0.001). The mean sedation score was less in group C than group N and D (P < 0.001). The patient satisfaction score showed the lowest degree of satisfaction in group C (p value < 0.001). Top-up doses consumed and total analgesic requirements were lower in groups N and D than in group C. There was a statistically significant difference between the studied groups regarding VAS over time (p value < 0.001), intraoperative bradycardia (p value 0.029), and shivering (p value 0.029).ConclusionThe addition of either nalbuphine or dexmedetomidine to epidural bupivacaine was effective for postoperative analgesia in terms of onset, duration, and patient satisfaction with the superiority of dexmedetomidine over nalbuphine.Trial registrationApproval from the research ethics committee of the Faculty of Medicine, Zagazig University was obtained with the reference number (ZU-IRB#:7045-15-8-2021) and it was registered under clinicaltrials.gov (NCT05041270) on registration date 13/09/2021.

Dataset Information

Dexmedetomidine versus fentanyl added to bupivacaine for epidural analgesia in combination with general anesthesia for elective lumbar disc operations: A prospective, randomized double-blinded study.

Publications

Dexmedetomidine versus fentanyl added to bupivacaine for epidural analgesia in combination with general anesthesia for elective lumbar disc operations: A prospective, randomized double-blinded study.

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