Resistance Under the Microscope

Tracking Information
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; (submitted: January 27, 2014)	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.
Original Primary Outcome Measures ICMJE; (submitted: September 27, 2011)	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.
Change History	Complete list of historical versions of study NCT01441843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 27, 2014)	Anxiety [ Time Frame: baseline; after surgery but before discharge; 1 week after surgery ]The State-Trait Anxiety Inventory (STAI) is used to assess anxiety. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of anxiety.; Fatigue [ Time Frame: baseline; 1 week after surgery ]The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of fatigue.; Aggression Regulation [ Time Frame: baseline; 1 week after surgery ]The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of aggression; Depressive Mood [ Time Frame: baseline; 1 week after surgery ]The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of depression.; Somatic Symptoms and Complaints [ Time Frame: Baseline; first postoperative working day; 1 week after surgery ]Medical records are used to assess somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure somatic symptoms and complaints.
Original Secondary Outcome Measures ICMJE; (submitted: September 27, 2011)	Change in Anxiety [ Time Frame: baseline up to 1 week after surgery ]The State-Trait Anxiety Inventory (STAI) is used to assess the change in anxiety. The STAI is the most widely used self-report measure of anxiety.; Change in Fatigue [ Time Frame: baseline up to 1 week after surgery ]The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue.; Change in Aggression regulation [ Time Frame: baseline up to 1 week after surgery ]The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression.; Change in Depressive moods [ Time Frame: baseline up to 1 week after surgery ]The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting.; Change in Somatic symptoms and complaints [ Time Frame: baseline up to 1 week after surgery ]Medical records are used to assess the change in somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure the change in somatic symptoms and complaints.
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.
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.
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
Condition ICMJE	Anxiety
Intervention ICMJE	Drug: Lorazepam Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery Other Name: Temesta; Drug: NaCl 0.9% (Sodium Chloride) Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery Other Name: NaCl 0.9%
Study Arms	Active Comparator: Lorazepam Lorazepam 4mg/4ml Intervention: Drug: Lorazepam; Placebo Comparator: NaCl 0.9% NaCl 0.9% 4ml Intervention: Drug: NaCl 0.9% (Sodium Chloride)
Publications *	Mijderwijk H, van Beek S, Klimek M, Duivenvoorden HJ, Grüne F, Stolker RJ. Lorazepam does not improve the quality of recovery in day-case surgery patients: a randomised placebo-controlled clinical trial. Eur J Anaesthesiol. 2013 Dec;30(12):743-51. doi: 10.1097/EJA.0b013e328361d395.; Mijderwijk H, Stolker RJ, Duivenvoorden HJ, Klimek M, Steyerberg EW. Clinical prediction model to identify vulnerable patients in ambulatory surgery: towards optimal medical decision-making. Can J Anaesth. 2016 Sep;63(9):1022-32. doi: 10.1007/s12630-016-0673-3. Epub 2016 Jun 9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 27, 2011)	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: patients > 18 years admitted to the Day-Case Surgery Department Erasmus MC Exclusion Criteria: insufficient command of the Dutch language; ophthalmology surgery; Extracorporeal Shock Wave Lithotripsy (ESWL)-, Gastrointestinal endoscopic intervention, Botox-, Abortion and Pain treatment; Use of psychopharmaceuticals; Contra-indication of lorazepam use
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Markus Klimek, MD, PhD Erasmus Medical Center
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