Resistance Under the Microscope
| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2011 | ||||
| Last Updated Date | February 25, 2013 | ||||
| Start Date ICMJE | October 2010 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Quality of Recovery [ Time Frame: baseline up to 1 week after surgery ] [ Designated as safety issue: No ] The Quality of Recovery Score - 40 (QoR-40) is used to assess the change in quality of recovery. The QoR-40 is widely used as outcome measurement in the field of anesthesia and day-case surgery. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01441843 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Resistance Under the Microscope | ||||
| Official Title ICMJE | Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design | ||||
| Brief Summary | The purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery. |
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| Detailed Description | Since the early 1980s, the investigators have seen a shift towards day-case surgery. Before surgery, many patients have negative feelings about the surgical procedure. These anxieties have various negative effects. To reduce this resistance preoperative administration of an anxiolytic drug is administered, typically a benzodiazepine. The investigators know that benzodiazepines are effective in reducing anxiety, but up to now there is nog good scientific evidence about the effectiveness of lorazepam on the quality of recovery in day-case surgery patients. The ultimate goal of our research project is to identify patients who would benefit from preoperative benzodiazepine administration and who not. Identification would substantially contribute to optimal medical decision making. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Anxiety | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01441843 | ||||
| Other Study ID Numbers ICMJE | NL3253507810 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Markus Klimek, Erasmus Medical Center | ||||
| Study Sponsor ICMJE | Erasmus Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Erasmus Medical Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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