Anxiety
Conditions
Keywords
quality of life, lorazepam, anxiety, premedication, surgery, Adult patients, Ambulatory Surgical Procedures, Postoperative Period
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.
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.
Interventions
DRUGLorazepam
Once 1mg \<75kg body weight, 1.5mg 75kg and \>75kg body weight, IV, before surgery
DRUGNaCl 0.9% (Sodium Chloride)
Once 1ml \<75kg body weight, 1.5ml 75kg or \>75kg body weight, IV, before surgery
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lorazepam Lorazepam 4mg/4ml
Lorazepam : Once 1mg \<75kg body weight, 1.5mg 75kg and \>75kg body weight, IV, before surgery | 198 |
| NaCl 0.9% NaCl 0.9% 4ml
NaCl 0.9% (Sodium Chloride) : Once 1ml \<75kg body weight, 1.5ml 75kg or \>75kg body weight, IV, before surgery | 200 |
| Total | 398 |
Baseline characteristics
| Characteristic | NaCl 0.9% | Lorazepam | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 191 Participants | 190 Participants | 381 Participants |
| Age, Continuous | 39.3 years STANDARD_DEVIATION 13.6 | 39.5 years STANDARD_DEVIATION 13.7 | 39.4 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment Netherlands | 200 participants | 198 participants | 398 participants |
| Sex: Female, Male Female | 85 Participants | 89 Participants | 174 Participants |
| Sex: Female, Male Male | 115 Participants | 109 Participants | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 200 | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 | 0 / 200 |
Outcome results
Primary
Quality of Recovery Score
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lorazepam | Quality of Recovery Score | Seventh postoperative day | 172.8 scores on a scale | Standard Deviation 21 |
| Lorazepam | Quality of Recovery Score | First postoperative working day | 174.5 scores on a scale | Standard Deviation 13 |
| Lorazepam | Quality of Recovery Score | Baseline | 177.2 scores on a scale | Standard Deviation 17.4 |
| NaCl 0.9% | Quality of Recovery Score | Seventh postoperative day | 176.3 scores on a scale | Standard Deviation 18.8 |
| NaCl 0.9% | Quality of Recovery Score | First postoperative working day | 176.4 scores on a scale | Standard Deviation 12.6 |
| NaCl 0.9% | Quality of Recovery Score | Baseline | 180.4 scores on a scale | Standard Deviation 17.5 |
Secondary
Aggression Regulation
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
Secondary
Anxiety
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
Secondary
Depressive Mood
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
Secondary
Fatigue
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
Secondary
Somatic Symptoms and Complaints
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