Study Results
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Basic Information
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RECRUITING
PHASE4
128 participants
INTERVENTIONAL
2013-07-04
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ketamina bolus plus Dexamethasone bolus plus infusion ketamine
Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA)
Ketamine
Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization
Dexamethasone
A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery.
Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration
Ketamine bolus plus ketamine infusion
Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA.
Ketamine
Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization
Physiologic saline
placebo
Dexametasone arm
Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
Dexamethasone
A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery.
Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration
Physiologic saline
placebo
Saline bolus
Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA
Physiologic saline
placebo
Interventions
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Ketamine
Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization
Dexamethasone
A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery.
Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration
Physiologic saline
placebo
Eligibility Criteria
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Inclusion Criteria
* Age\> 18 years
* ASA I-III.
* Lumbar arthrodesis.
* Patients who have signed the preoperative informed consent for participation in the study.
Exclusion Criteria
* Glaucoma
* History of allergy to ketamine, dexamethasone, or morphic chloride
* Dementia or inability to understand IC and study
* Pluricomplicated diabetes mellitus difficult to control
* Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug
18 Years
ALL
No
Sponsors
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
OTHER
Responsible Party
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Dr Emili Leon
Principal Investigator
Principal Investigators
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Emili Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Dr Josep Trueta and Hospital Santa Caterina
Locations
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Hospital Dr Josep Trueta
Girona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EudraCT number 2012-002518-38
Identifier Type: -
Identifier Source: org_study_id
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