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| Name | Class |
|---|---|
| Jules Bordet Institute | OTHER |
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66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other group an opioid free one. The hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.
Opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFA (opioid free anesthesia) | Experimental | 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. |
|
| OA (opioid anesthesia) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFA | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| QoR-40 | Patient comfort was assessed via the QoR-40 questionnaire 24hours post-operatively. | 24 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative NRS | Pain assessment via NRS | during 24 hours post-operative |
| Post-operative piritramide consumption | during the first 24 hours post-operative |
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Inclusion Criteria:
Exclusion criteria were the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | Brussels Capital | 1000 | Belgium |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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