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Resistance Under the Microscope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441843
First Posted: September 28, 2011
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Markus Klimek, Erasmus Medical Center
Results First Submitted: August 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anxiety
Interventions: Drug: Lorazepam
Drug: NaCl 0.9% (Sodium Chloride)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lorazepam

Lorazepam 4mg/4ml

Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery

NaCl 0.9%

NaCl 0.9% 4ml

NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery


Participant Flow:   Overall Study
    Lorazepam   NaCl 0.9%
STARTED   200   200 
COMPLETED   188   195 
NOT COMPLETED   12   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
In retrospect, two patients in the lorazepam group should not have been included due to an administrative error. Data for these two patients were, therefore, excluded from analysis.

Reporting Groups
  Description
Lorazepam

Lorazepam 4mg/4ml

Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery

NaCl 0.9%

NaCl 0.9% 4ml

NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery

Total Total of all reporting groups

Baseline Measures
   Lorazepam   NaCl 0.9%   Total 
Overall Participants Analyzed 
[Units: Participants]
 198   200   398 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   190   191   381 
>=65 years   8   9   17 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.5  (13.7)   39.3  (13.6)   39.4  (13.6) 
Gender 
[Units: Participants]
     
Female   89   85   174 
Male   109   115   224 
Region of Enrollment 
[Units: Participants]
     
Netherlands   198   200   398 


  Outcome Measures

1.  Primary:   Quality of Recovery Score   [ Time Frame: Baseline; first postoperative working day; seventh postoperative day. ]

2.  Secondary:   Anxiety   [ Time Frame: baseline; after surgery but before discharge; 1 week after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Fatigue   [ Time Frame: baseline; 1 week after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Aggression Regulation   [ Time Frame: baseline; 1 week after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Depressive Mood   [ Time Frame: baseline; 1 week after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Somatic Symptoms and Complaints   [ Time Frame: Baseline; first postoperative working day; 1 week after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. M. Klimek
Organization: Erasmus University Medical Centre
phone: +31107033713
e-mail: m.klimek@erasmusmc.nl


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Markus Klimek, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01441843     History of Changes
Other Study ID Numbers: NL3253507810
First Submitted: September 22, 2011
First Posted: September 28, 2011
Results First Submitted: August 29, 2013
Results First Posted: March 10, 2014
Last Update Posted: March 29, 2016