Resistance Under the Microscope

• Sponsor: Erasmus Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01441843
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 36.3

Study Details

Study Description

Brief Summary

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

This study data will also be used for further research aiming to identify vulnerable patients in the day-case surgery setting.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Drug: Lorazepam; Drug: NaCl 0.9% (Sodium Chloride)	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Resistance Under the Microscope; a Randomized Placebo Controlled Parallel Group Design
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lorazepam Lorazepam 4mg/4ml	Drug: Lorazepam; Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery; Other Names: 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 Names: NaCl 0.9%

Outcome Measures

Primary Outcome Measures

1. Quality of Recovery Score [Baseline; first postoperative working day; seventh postoperative day.]

   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

1. Anxiety [baseline; after surgery but before discharge; 1 week after surgery]

   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.

2. Fatigue [baseline; 1 week after surgery]

   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.

3. Aggression Regulation [baseline; 1 week after surgery]

   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

4. Depressive Mood [baseline; 1 week after surgery]

   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.

5. Somatic Symptoms and Complaints [Baseline; first postoperative working day; 1 week after surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Erasmus University Medical Center	Rotterdam		Netherlands	3015CE

Sponsors and Collaborators

• Erasmus Medical Center

Investigators

• Principal Investigator: Markus Klimek, MD, PhD, Erasmus Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Markus Klimek, Vice-head of Anesthesiology, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT01441843
• Other Study ID Numbers: NL3253507810
• First Posted: Sep 28, 2011
• Last Update Posted: Mar 1, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Markus Klimek, Vice-head of Anesthesiology, Erasmus Medical Center: quality of life; lorazepam; anxiety; premedication; surgery; Adult patients; Ambulatory Surgical Procedures; Postoperative Period
• Additional relevant MeSH terms: Lorazepam

Study Results

Participant Flow

Arm/Group Title	Lorazepam	NaCl 0.9%
Arm/Group Description	Lorazepam 4mg/4ml Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery	NaCl 0.9% 4ml NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery
Period Title: Overall Study
STARTED	200	200
COMPLETED	188	195
NOT COMPLETED	12	5

Baseline Characteristics

Arm/Group Title	Lorazepam	NaCl 0.9%	Total
Arm/Group Description	Lorazepam 4mg/4ml Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery	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 of all reporting groups
Overall Participants	198	200	398
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	190 96%	191 95.5%	381 95.7%
>=65 years	8 4%	9 4.5%	17 4.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.5 (13.7)	39.3 (13.6)	39.4 (13.6)
Sex: Female, Male (Count of Participants)
Female	89 44.9%	85 42.5%	174 43.7%
Male	109 55.1%	115 57.5%	224 56.3%
Region of Enrollment (participants) [Number]
Netherlands	198 100%	200 100%	398 100%

Outcome Measures

1. Primary Outcome

Title	Quality of Recovery Score
Description	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.
Time Frame	Baseline; first postoperative working day; seventh postoperative day.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lorazepam	NaCl 0.9%
Arm/Group Description	Lorazepam 4mg/4ml Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery	NaCl 0.9% 4ml NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery
Measure Participants	188	195
Seventh postoperative day	172.8 (21.0)	176.3 (18.8)
First postoperative working day	174.5 (13.0)	176.4 (12.6)
Baseline	177.2 (17.4)	180.4 (17.5)

2. Secondary Outcome

Title	Anxiety
Description	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.
Time Frame	baseline; after surgery but before discharge; 1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Fatigue
Description	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.
Time Frame	baseline; 1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Aggression Regulation
Description	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
Time Frame	baseline; 1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Depressive Mood
Description	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.
Time Frame	baseline; 1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Somatic Symptoms and Complaints
Description	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.
Time Frame	Baseline; first postoperative working day; 1 week after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Lorazepam		NaCl 0.9%
Arm/Group Description	Lorazepam 4mg/4ml Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery		NaCl 0.9% 4ml NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery
All Cause Mortality
	Lorazepam		NaCl 0.9%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lorazepam		NaCl 0.9%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/200 (0%)
Other (Not Including Serious) Adverse Events
	Lorazepam		NaCl 0.9%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/200 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.