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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COMPLETED
PHASE4
66 participants
INTERVENTIONAL
2014-09-30
2015-07-31
Brief Summary
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Detailed Description
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The purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. A multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia.
The hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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OFA (opioid free anesthesia)
All drugs were given IV. Induction in the opioid free group began with a loading dose of clonidine (0.2 mcg kg-1), a bolus of ketamine (0.3 mg kg -1) lidocaine (1.5 mg kg -1) and a bolus of propofol (2-3 mg kg -1).
General anesthesia was maintained with sevoflurane (MAC: 1) (adapted according to hemodynamic stability).
Upon the incision, acetaminophen (1000 mg) and diclofenac (75 mg) were given in both groups. A bolus of ketamine (0.2mg kg -1) was given if necessary in the opioid free group (up to three bolus max. were permitted).
A bolus of piritramide (0.03 mg kg -1) was administered upon subcutaneous closure.
Postoperative pain was treated with IV acetaminophen (1000 mg) every 6 h for the first 24 hours and IV diclofenac (75 mg) every 12 h for the first 24 hours. Patients received a PCIA (patient-controlled intravenous analgesia) pump of piritramide.
OFA
OA (opioid anesthesia)
All drugs were given IV. Induction in the opioid group began with remifentanil TCI, a bolus of ketamine (0.3 mg kg -1) lidocaine (1.5 mg kg -1) and a bolus of propofol (2-3 mg kg -1).
General anesthesia was maintained with sevoflurane (MAC: 1). Upon the incision, acetaminophen (1000 mg) and diclofenac (75 mg) were given in both groups.
A bolus of piritramide (0.03 mg kg -1) was administered upon subcutaneous closure.
Postoperative pain was treated with IV acetaminophen (1000 mg) every 6 h for the first 24 hours and IV diclofenac (75 mg) every 12 h for the first 24 hours. Patients received a PCIA (patient-controlled intravenous analgesia) pump of piritramide.
No interventions assigned to this group
Interventions
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OFA
Eligibility Criteria
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Inclusion Criteria
* Patients with an ASA physical status of II were included.
* Knowledge of either French, English or Dutch was required.
Exclusion Criteria
FEMALE
No
Sponsors
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Jules Bordet Institute
OTHER
Université Libre de Bruxelles
OTHER
Responsible Party
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Sarah Saxena
M.D.
Locations
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Institut Jules Bordet
Brussels, Brussels Capital, Belgium
Countries
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Other Identifiers
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CE2261
Identifier Type: -
Identifier Source: org_study_id
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