Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
Who is this study for? Patients undergoing lumbar arthrodesis
What treatments are being studied? Ketamine+Dexamethasone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female
• Age\> 18 years
• ASA I-III.
• Lumbar arthrodesis.
• Patients who have signed the preoperative informed consent for participation in the study.
Locations
Other Locations
Spain
Hospital Dr Josep Trueta
RECRUITING
Girona
Contact Information
Primary
Cristina Martinez, Sc
cmartinez@idibgi.org
972940200
Backup
Emili Leon, MD
emili_leon@yahoo.es
972940200
Time Frame
Start Date: 2013-07-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 128
Treatments
Experimental: 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)
Experimental: 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.
Active_comparator: Dexametasone arm
Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
Placebo_comparator: Saline bolus
Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA
Related Therapeutic Areas
Sponsors
Leads: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta