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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017117-30 | EudraCT Number | ||
| 09/15863 | Other Identifier | Norwegian Medicines Agency |
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The purpose of this study is to establish validated outcome measures for Postoperative Fatigue and Postoperative nausea, and to compare clinical impact of postanaesthetic symptoms during first week after Propofol or Desflurane based anaesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desflurane | Active Comparator | Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. |
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| Propofol | Active Comparator | Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of fatigue after anaesthesia based on propofol or desflurane | Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively. | Within the first week postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane | PONV scales; 4-point Likert Scale and 11-point NRS Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively. | Within the first week postoperatively |
| Fatigue scale validation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Telemark Hospital | Skien | Telemark | N-3710 | Norway |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Desflurane | Drug | Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep |
|
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To ensure validated outcome measures we will perform validation and comparison of two different fatigue scales (Chalder Fatigue Scale and Identity-Consequences Fatigue Scale). This will primarily be performed in a mixed surgical population. In addition the scales will also be validated in palliative patients, patients with possible CFS/ME diagnosis and patients with chronic pain. Data aquisition will be cross-sectional, but the surgical population will also yield longitudinal data (preop. and 3rd postoperative day) |
| See under "Description": |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |