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
60 participants
INTERVENTIONAL
2022-11-01
2024-11-01
Brief Summary
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Detailed Description
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This double blind clinical trial aims to investigate the possible reduction of opioid use during lumbar spine surgery by administering ketamine and lidocaine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Ketamine-Lidocaine (KL) group will receive a continuous infusion of ketamine and lidocaine, during the surgery and shortly after.
Both infusions will be administered blindly. Fentanyl and morphine will be administered to each patient so as to maintain hemodynamic stability and pain relief. The study will eventually compare the need for bolus doses of fentanyl during the surgery and morphine shortly after in each group.
Multiple hemodynamic parameters, analgesic consumption, possible side effects, patient satisfaction and the Oswestry low back pain disability questionnaire will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe
ketamine-lidocaine
In the KL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine at predefined concentrations.
As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution
: remifentanil group syringe of remifentanil
Remifentanil
In the Remifentanil group, patients will be administered in a total volume of 20 mL, 2 mcg/kg of fentanyl. As maintenance, they will be receiving 1 mL/10kg/h of a remifentanil solution
Interventions
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ketamine-lidocaine
In the KL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine at predefined concentrations.
As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution
Remifentanil
In the Remifentanil group, patients will be administered in a total volume of 20 mL, 2 mcg/kg of fentanyl. As maintenance, they will be receiving 1 mL/10kg/h of a remifentanil solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) class I-III
* elective spine surgery
Exclusion Criteria
* contraindications to local anesthetic administration
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* bradycardia(\<55 beats/minute)
* drug or alcohol abuse
* language or communication barriers lack of informed consent
18 Years
75 Years
ALL
Yes
Sponsors
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Aretaieion University Hospital
OTHER
Evangelismos Hospital
OTHER
Responsible Party
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Athanasios Vaiopoulos
Anesthesia Resident
Principal Investigators
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Kassiani Theodoraki
Role: PRINCIPAL_INVESTIGATOR
Aretaieion University Hospital, Athens, Greece
Locations
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Evangelismos General Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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Athanasios Vaiopoulos
Role: primary
Other Identifiers
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254/13-07-2022Β
Identifier Type: -
Identifier Source: org_study_id
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