Resistance Under the Microscope

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Markus Klimek, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01441843
First received: September 22, 2011
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: August 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anxiety
Interventions: Drug: Lorazepam
Drug: NaCl 0.9% (Sodium Chloride)

  Participant Flow
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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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Fatigue   [ Time Frame: baseline; 1 week after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

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

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


  Serious Adverse Events


  Other Adverse Events


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


Limitations and Caveats
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.  


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:

Responsible Party: Markus Klimek, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01441843     History of Changes
Other Study ID Numbers: NL3253507810
Study First Received: September 22, 2011
Results First Received: August 29, 2013
Last Updated: January 27, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)