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Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce preemptive analgesia when administrated before tissue injury , thus decreasing the subsequent sensation of pain.
Following Ethics Committee approval and informed patients consent, Ninety patients 20-60 yr old ASA physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and the placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain relief as needed .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fentanyl | Active Comparator | Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery) |
|
| placebo | Placebo Comparator | Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery) |
|
| magnesium sulphate | Active Comparator | Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first requirement of analgesic supplement | analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4) | time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution |
| postoperative analgesic requirements | postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain).Each administration was initiated by patient request( VRS>4) | 12 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory block onset time will be assessed by a pinprick test | The onset of sensory block was defined as the time between the end of injection of the intrathecal anesthetic and the absence of pain at the T10 dermatome | sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection |
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Inclusion Criteria:
.patients with American Society of Anesthesiologists(ASA) physical status I and
II, undergoing elective femur surgery
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marzieh Beigom Khezri, assistant professor | Qazvin medical science university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qazvin university of medical science | Qazvin | Qazvin Province | 34197/59811 | Iran |
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| placebo(distilled water) | Drug | Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery) |
|
| magnesium sulphate | Drug | Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery) |
|
| duration of sensory block will be assessed by a pinprick test |
The duration of sensory block was defined as the time between the end of injection of the intrathecal anestheticthe time and regression of two segments from the maximum block height |
| sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection |
| the onset of motor block will be assessed by the modified Bromage score | The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1 | every10 seconds following intrathecal injection |
| duration of motor block will be assessed by the modified Bromage score | duration of motor block was defined the time from intrathecal injection to Bromage score0 | every 5 minuts following intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 5min before the intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 2minutes after intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 4minutes after intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 6minutes after intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 8minutes after intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 10minutes after intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 15minutes after intrathecal injection |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 20minutes after intrathecal injection |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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