Resistance Under the Microscope
|ClinicalTrials.gov Identifier: NCT01441843|
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : March 10, 2014
Last Update Posted : March 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Drug: Lorazepam Drug: NaCl 0.9% (Sodium Chloride)||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design|
|Study Start Date :||October 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Active Comparator: Lorazepam
Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery
Other Name: Temesta
Placebo Comparator: NaCl 0.9%
NaCl 0.9% 4ml
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%
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441843
|Erasmus University Medical Center|
|Rotterdam, Netherlands, 3015CE|
|Principal Investigator:||Markus Klimek, MD, PhD||Erasmus Medical Center|