| Efectos del midazolam intratecal en la anestesia espinal: estudio randomizado, prospectivo, con casos control |
Effects of intrathecal midazolam in spinal anaesthesia: a prospective randomised case control study.
Shadangi BK, Garg R, Pandey R, Das T.
Department of Anaesthesiology, All India Institute of Medical Scences, Ansari Nagar, New Delhi 110029, India. drrgarg@hotmail.com.
Singapore Med J. 2011 Jun;52(6):432-5.
Abstract
Introduction: Subarachnoid block with local anaesthetics and adjuvants has been extensively used for surgery. Intrathecal midazolam produces antinociception and potentiates the effect of local anaesthetics. We compared intrathecal bupivacaine with and without midazolam to assess its effect on the duration of sensory block, motor block and pain relief. Methods: A total of 100 patients scheduled for elective lower abdominal, lower limb and gynaecological procedures were selected to participate in this prospective, randomised, double-blind study. Patients were randomly allocated into two groups for intrathecal drug administration. Group B received 3 mL 0.5 percent bupivacaine with 0.4 mL saline, and group BM received 3 mL 0.5 percent bupivacaine and 0.4 mL (2 mg) midazolam mixture. The onset, duration of sensory/motor block, time to first rescue analgesia and side effects were noted. Results: Demographic profile and duration of surgery were comparable between the two groups. The onset of sensory (4.8 versus 4.6 min) and motor block (5.9 versus 6 min) was also comparable between the groups. The duration of sensory blockade was prolonged in the midazolam group (90.8 versus 115.8 min, p-value is 0.001), while the duration of motor blockade was comparable (151.8 versus 151.3 min, p-value is 0.51). The duration of effective analgesia was significantly longer in the midazolam group compared to the control group (121.3 versus 221.1 min, p-value is 0.001). Sedation score was comparable in the two groups. Conclusion: The addition of preservative-free midazolam to bupivacaine intrathecally resulted in prolonged postoperative analgesia without increasing motor blockhttp://smj.sma.org.sg/5206/5206a7.pdf
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| El uso de midazolam intratecal en los seres humanos: un estudio de caso del proceso |
The use of intrathecal midazolam in humans: a case study of process.
Yaksh TL, Allen JW.
Department of Anesthesiology, University of California-San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0818, USA. tyaksh@ucsd.edu
Anesth Analg. 2004 Jun;98(6):1536-45
Abstract
Early preclinical work demonstrated the potential role of spinal benzodiazepine pharmacology in regulating spinal nociceptive transmission. We review this preclinical activity and the evolving implementation of intrathecal midazolam in humans for pain management. Important elements in this development for use in humans are issues pertinent to safety and the preclinical reports that have increased our understanding of intrathecal midazolam toxicity. We seek to emphasize the time course of these studies and how they merged to provide enabling data that drove the clinical implementation. In the case of midazolam, we point to the potential issues that arose when preclinical safety data were unreasonably ignored and how consideration of preclinical safety data can serve to facilitate drug development by demonstrating reasonable safety profiles that document the minimal degree of potential risk to the patient. Issues that are of continuing relevance to the use of intrathecal midazolam, including issues of formulation and kinetics, are considered. IMPLICATIONS: The intrathecal use of midazolam has evolved over 20 years though a combination of preclinical and clinical investigations. We review the time course of this development to define critical elements that should be pursued in reducing the risk associated with the clinical use of a novel spinal drughttp://www.anesthesia-analgesia.org/content/98/6/1536.full.pdf+html
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| Midazolam intratecal I: Estudio de cohortes investigando su seguridad |
Intrathecal midazolam I: a cohort study investigating safety.
Tucker AP, Lai C, Nadeson R, Goodchild CS.
Department of Anaesthesia, Monash Medical Centre, Monash University, 246 Clayton Road, Victoria 3168, Australia.research@southernhealth.org.au
Anesth Analg. 2004 Jun;98(6):1512-20
Abstract
Despite conflicting evidence regarding the safety of intrathecal midazolam from animal investigations, its clinical use is increasing. We investigated the potential of intrathecal midazolam to produce symptomatology suggestive of neurological damage. This study compared two cohorts of patients who received intrathecal anesthesia with or without intrathecal midazolam (2 mg). Eighteen risk factors were evaluated with respect to symptoms representing potential neurological complications. The definitions of these symptoms were made wide to maximize the chance of counting patients with neurological sequelae after intrathecal injections. Eleven-hundred patients were followed up prospectively during the first postoperative week by a hospital chart review and 1 mo later by a mailed questionnaire. Symptoms suggestive of neurological impairment, including motor or sensory changes and bladder or bowel dysfunction, were investigated. Intrathecal midazolam was not associated with an increased risk of neurologic symptoms. In contrast, neurologic symptoms were found to be increased by age >70 yr (relative risk, 8.72) and the occurrence of a blood-stained spinal tap (relative risk, 8.07). The administration of intrathecal midazolam, 2 mg, did not increase the occurrence of neurologic or urologic symptoms, as suggested by some preclinical animal experimentation. IMPLICATIONS: Intrathecal midazolam provides segmental analgesia, but conflicting animal studies have cast doubts on its safety. This investigation studied the effect of intrathecal midazolam by observing two cohorts of patients. In clinical practice, intrathecal midazolam (2 mg) did not increase adverse neurological symptoms compared with conventional therapies
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| Midazolam intratecal II: combinación con fentanil intratecal en trabajo de parto |
Intrathecal midazolam II: combination with intrathecal fentanyl for labor pain.
Tucker AP, Mezzatesta J, Nadeson R, Goodchild CS.
Department of Anaesthesia, Monash Medical Centre, Monash University, 246 Clayton Road, Victoria 3168, Australia.adam.tucker@med.monash.edu.au
Anesth Analg. 2004 Jun;98(6):1521-7
Abstract
Recent investigations have sought to improve intrathecal analgesia by combining opioids with other classes of analgesics. In this study we assessed the ability of intrathecal midazolam to increase the potency and duration of the analgesic effects of intrathecal fentanyl without causing adverse effects. Thirty parturients with cervical dilations 2-6 cm were randomized to receive either intrathecal midazolam 2 mg, fentanyl 10 micro g, or both combined to initiate analgesia. Pain scores were recorded before and at 5-min intervals for 30 min after the injection and then every 30 minutes until the patient requested further analgesia. The presence and severity of nausea, emesis, pruritus, headache, and sedation, in addition to arterial blood pressure, heart rate, respiratory rate, sensory changes to ice, motor impairment, cardiotocograph, and Apgar score were also recorded. The parturients were assessed after 2 days and 1 mo for neurologic impairment. Preinjection pain scores were unaltered by intrathecal midazolam alone and moderately decreased by fentanyl. Intrathecal midazolam increased the analgesic effect of fentanyl. No treatment altered cardiorespiratory variables or caused motor impairment. The addition of intrathecal midazolam to fentanyl did not increase the occurrence of any maternal adverse event or abnormalities on the cardiotocograph. We conclude that intrathecal midazolam enhanced the analgesic effect of fentanyl without increasing maternal or fetal adverse effects. IMPLICATIONS: Treatment of labor pain with epidural injections of local anesthetic is complicated by decreases in arterial blood pressure and leg weakness. This study showed that a mixture of two drugs, fentanyl and midazolam, could provide powerful pain relief when the drugs were given together spinally without such side effects
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