Resistance Under the Microscope - Full Text View

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:

MedlinePlus related topics: Anxiety

Drug Information available for: Lorazepam Sodium chloride

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

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

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

No publications provided

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
Last Updated:	February 25, 2013
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:

Anxiety Disorders
Mental Disorders
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents

Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013