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
  Purpose

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


Condition Intervention Phase
Anxiety
Drug: Lorazepam
Drug: NaCl 0.9% (Sodium Chloride)
Phase 4

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
Official Title: Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 400
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lorazepam
Lorazepam 4mg/4ml
Drug: 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%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441843

Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Markus Klimek, MD, PhD Erasmus Medical Center
  More Information

Publications:
Responsible Party: Markus Klimek, Vice-head of Anesthesiology, 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)

Keywords provided by Erasmus Medical Center:
quality of life
lorazepam
anxiety
premedication
surgery
Adult patients
Ambulatory Surgical Procedures
Postoperative Period

Additional relevant MeSH terms:
Lorazepam
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014