Trial · NCT01441843
Resistance Under the Microscope
NCT01441843, Phase 4, Completed, Erasmus Medical Center; results first posted 2014-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Resistance Under the Microscope. Trials, record NCT01441843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01441843
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Resistance Under the Microscope
- NCT number
- NCT01441843
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 400 participants, actual
- Lead sponsor
- Erasmus Medical Center
- Conditions
- Anxiety
- Interventions
- Lorazepam, NaCl 0.9% (Sodium Chloride)
- First posted
- 2011-09-28
- Last updated
- 2023-09-25
- Results first posted
- 2014-03-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quality of Recovery Score | Baseline; first postoperative working day; seventh postoperative day. | scores on a scale | MEAN | |
| SECONDARY | Anxiety | baseline; after surgery but before discharge; 1 week after surgery | |||
| SECONDARY | Fatigue | baseline; 1 week after surgery | |||
| SECONDARY | Aggression Regulation | baseline; 1 week after surgery | |||
| SECONDARY | Depressive Mood | baseline; 1 week after surgery | |||
| SECONDARY | Somatic Symptoms and Complaints | Baseline; first postoperative working day; 1 week after surgery |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quality of Recovery Score | Lorazepam | Seventh postoperative day | 172.8 | Standard Deviation 21.0 | scores on a scale |
| Quality of Recovery Score | NaCl 0.9% | Seventh postoperative day | 176.3 | Standard Deviation 18.8 | scores on a scale |
| Quality of Recovery Score | Lorazepam | First postoperative working day | 174.5 | Standard Deviation 13.0 | scores on a scale |
| Quality of Recovery Score | NaCl 0.9% | First postoperative working day | 176.4 | Standard Deviation 12.6 | scores on a scale |
| Quality of Recovery Score | Lorazepam | Baseline | 177.2 | Standard Deviation 17.4 | scores on a scale |
| Quality of Recovery Score | NaCl 0.9% | Baseline | 180.4 | Standard Deviation 17.5 | scores on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lorazepam | 200 | |
| Overall Study | STARTED | NaCl 0.9% | 200 | |
| Overall Study | COMPLETED | Lorazepam | 188 | |
| Overall Study | COMPLETED | NaCl 0.9% | 195 | |
| Overall Study | NOT COMPLETED | Lorazepam | 12 | |
| Overall Study | NOT COMPLETED | NaCl 0.9% | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lorazepam | ||
| Total, all-cause mortality | NaCl 0.9% | ||
| Total, other adverse events | Lorazepam | 0 | 200 |
| Total, other adverse events | NaCl 0.9% | 0 | 200 |
| Total, serious adverse events | Lorazepam | 0 | 200 |
| Total, serious adverse events | NaCl 0.9% | 0 | 200 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lorazepam vs NaCl 0.9%: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01441843
GET https://conductscience.org/api/trials/v1/NCT01441843/registered