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

September 22, 2011
January 27, 2014
October 2010
September 2011   (final data collection date for primary outcome measure)
Quality of Recovery Score [ Time Frame: Baseline; first postoperative working day; seventh postoperative day. ] [ Designated as safety issue: No ]

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.

Change in Quality of Recovery [ Time Frame: baseline up to 1 week after surgery ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01441843 on ClinicalTrials.gov Archive Site
  • Anxiety [ Time Frame: baseline; after surgery but before discharge; 1 week after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Change in Anxiety [ Time Frame: baseline up to 1 week after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
Resistance Under the Microscope
Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design

The purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety
  • 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%
  • 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)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01441843
NL3253507810
No
Markus Klimek, Erasmus Medical Center
Erasmus Medical Center
Not Provided
Principal Investigator: Markus Klimek, MD, PhD Erasmus Medical Center
Erasmus Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP