The Comparison of Analgesia Methods Used for Spinal Surgery
NCT ID: NCT04603638
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
82 participants
INTERVENTIONAL
2020-03-04
2022-02-04
Brief Summary
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The use of PCA (patient controlled analgesia) device is available in both groups.In post-operative period, magnesium infusion will be continued for 12 h. Only 100cc isotonic will be given without using magnesium to the other group. VAS (visual analog scale) score will be recorded at postoperative 30. minutes and 2,6,12,18,24 hours. In routine administration, the patient should be given 2 mg of morphine if vas\>4 and the maximum dose will be increased to 10 mg.
Detailed Description
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Standard anesthesia monitoring will be performed for patients taken to the operation room. Routine anesthesia induction will be performed. In the prone position, anesthesia maintenance will be provided using the infusion of propofol and remifentanil.
Our clinic; PCA (patient-controlled analgesia) device with intravenous morphine is used routinely for postoperative analgesia.In this study ;two randomized groups will be created. It will give iv magnesium(in the intraoperative period at a dose of 40mg / kg, within 30 minutes after induction) to a blindly designated group. The other group will be given only isotonic. After in post-operative period, magnesium infusion will be continued for 12 hours (40mg / kg). Magnesium sulfate will be given in 100 cc isotonic. In the other group, only 100cc isotonic will be given without using magnesium. All patients will be awakened after the analgesic agents (0,1mg / kg morphine, 15mg / kg paracetamol, nsaid) are used in routine practice and will be followed up for intensive care.
The use of PCA device is available in both groups. vas score will be recorded postoperative 30. minutes and 2,6,12,18,24 hours. In routine administration, the patient should be given 2 mg of morphine if vas\>4 and the maximum dose will be increased to 10 mg.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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magnesium
participations will be given intravenous magnesium.
Magnesium
40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h)
control
participations will be given intravenous isotonic.
Isotonic
100 ml
Interventions
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Magnesium
40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h)
Isotonic
100 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with posterior instrumentation surgery of 3 or more levels under general anesthesia with a cobb angle of 40 degrees and above
* Patients who will be awakened after the surgery is completed and intensive care follow-up
* Patients with ASA classification 1-3
* Patients with creatine value \<1.3 g / dl
Exclusion Criteria
* Having a psychiatric illness
* Patients who should not be awakened after surgery but should be followed up intubated and sedated
* Patients who cannot provide adequate cooperation for scoring
* Patients with chronic opioid use and / or substance use
* Patients with ASA classification\> 3
* Patients with a creatinine value of 1.3 g / dl and higher
18 Years
75 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Dilek Hundur
Resident at Anesthesiology and Reanimation
Principal Investigators
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Mehmet Ilke Buget
Role: PRINCIPAL_INVESTIGATOR
Istanbul University
Locations
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Istanbul University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Jabbour HJ, Naccache NM, Jawish RJ, Abou Zeid HA, Jabbour KB, Rabbaa-Khabbaz LG, Ghanem IB, Yazbeck PH. Ketamine and magnesium association reduces morphine consumption after scoliosis surgery: prospective randomised double-blind study. Acta Anaesthesiol Scand. 2014 May;58(5):572-9. doi: 10.1111/aas.12304. Epub 2014 Mar 17.
Other Identifiers
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2019/1458
Identifier Type: -
Identifier Source: org_study_id