Resistance Under the Microscope
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ClinicalTrials.gov Identifier: NCT01441843 |
Recruitment Status
:
Completed
First Posted
: September 28, 2011
Results First Posted
: March 10, 2014
Last Update Posted
: March 1, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | September 22, 2011 | |||
First Posted Date ICMJE | September 28, 2011 | |||
Results First Submitted Date | August 29, 2013 | |||
Results First Posted Date | March 10, 2014 | |||
Last Update Posted Date | March 1, 2018 | |||
Study Start Date ICMJE | October 2010 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Quality of Recovery Score [ Time Frame: Baseline; first postoperative working day; seventh postoperative day. ] The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery. Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery. |
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Original Primary Outcome Measures ICMJE |
Change in Quality of Recovery [ Time Frame: baseline up to 1 week after surgery ] 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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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 |
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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. This study data will also be used for further research aiming to identify vulnerable patients in the day-case surgery setting. |
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Anxiety | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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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 | |||
Actual Enrollment ICMJE |
400 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | September 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01441843 | |||
Other Study ID Numbers ICMJE | NL3253507810 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Markus Klimek, Erasmus Medical Center | |||
Study Sponsor ICMJE | Erasmus Medical Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Erasmus Medical Center | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |