Postoperative PeriodPhase 4WOLIINCT01993459
The Effects of Midazolam on the Quality of Postoperative Recovery
A Phase 4 study testing Midazolam and NaCl (sodium chloride) 0,9% in people with Postoperative Period and Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Period, Anxiety, Fatigue
- What is being tested?
- Midazolam and NaCl (sodium chloride) 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2014to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patiënts operated with a laparotomy in the Erasmus Medical Center of Rotterdam, older than 18 years and planned for a postoperative stay for a minimum of 3 days
Who cannot join
- Pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Effects of Midazolam on the Quality of Postoperative Recovery in Patients
The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.
- Conditions
- Postoperative Period, Anxiety, Fatigue, Depression, Aggression
- Being tested
- Midazolam, NaCl (sodium chloride) 0,9%
- Keywords
- Quality of Recovery
- Medical subject headings
- Anxiety Disorders, Fatigue, Depression, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Dormicum
We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery
NaCl (sodium chloride) 0,9%Drug
Also called saline solution, sodium chloride solution
We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Midazolam intravenous | Experimental | 3mg/ml midazolam given intravenously Receives: Drug: Midazolam |
| NaCl (sodium chloride) 0,9% | Placebo comparator | NaCl (sodium chloride) 0,9% given intravenously 3ml. Receives: Drug: NaCl (sodium chloride) 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Recovery (QoR-40 Scale)
Measured: baseline, workday 3 postoperative, workday 7 postoperative
Secondary outcomes (9)
Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)
Measured: baseline, workday 1 postoperative, workday 7 postoperative
Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS)
Measured: baseline, workday 1 postoperative, workday 7 postoperative
Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)
Measured: baseline, workday 7 postoperative
Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).
Measured: baseline, workday 7 postoperative
Change in Systolic bloodpressure
Measured: baseline, workday 1 postoperative
Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)
Measured: baseline, workday 7 postoperative
Change in Diastolic Blood pressure
Measured: baseline, workday 1 postoperative
Temperature after surgery measured with an ear thermometer
Measured: directly after surgery
Change in Heart Rate
Measured: preoperatively, during surgery and postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PeriodStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan van Beek, Erasmus Medical Center
- Investigators
- Robert Jan Stolker, MD, PhD, Study chair, Erasmus MC Rotterdam AnesthesiologyMarkus Klimek, MD, PhD, Study chair, Erasmus MC Rotterdam AnesthesiologyStefan van Beek, BSc, Principal investigator, Erasmus MC Rotterdam Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993459
- Sponsor's protocol ID
- 14091991
- Acronym
- WOLII
- Status last verified
- Jan 2016
- First submitted
- 29 Oct 2013
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
van Beek S, Kroon J, Rijs K, Mijderwijk HJ, Klimek M, Stolker RJ. The effect of midazolam as premedication on the quality of postoperative recovery after laparotomy: a randomized clinical trial. Can J Anaesth. 2020 Jan;67(1):32-41. doi: 10.1007/s12630-019-01494-6. Epub 2019 Oct 1.
PubMed 31576513
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effects of Midazolam on the Quality of Postoperative Recovery in Patients
- ClinicalTrials.gov ID
- NCT01993459
- Acronym / sponsor ID
- WOLII / 14091991
- Conditions
- Postoperative Period, Anxiety, Fatigue, Depression, Aggression
- Keywords
- Quality of Recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam intravenous | Experimental | Drug: Midazolam3mg/ml midazolam given intravenously |
| NaCl (sodium chloride) 0,9% | Placebo comparator | Drug: NaCl (sodium chloride) 0,9%NaCl (sodium chloride) 0,9% given intravenously 3ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patiënts operated with a laparotomy in the Erasmus Medical Center of Rotterdam, older than 18 years and planned for a postoperative stay for a minimum of 3 days
Key exclusion criteria (1 listed)
- Pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: DormicumWe will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery | Drug | Midazolam intravenous |
| NaCl (sodium chloride) 0,9%Also: saline solution, sodium chloride solutionWe will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery | Drug | NaCl (sodium chloride) 0,9% |
Primary outcome
Change in Quality of Recovery (QoR-40 Scale)
Time frame: baseline, workday 3 postoperative, workday 7 postoperative
9 secondary outcomes
Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)
Time frame: baseline, workday 1 postoperative, workday 7 postoperative
Change in depressive moods and anxiety measured by a Dutch translation of the Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline, workday 1 postoperative, workday 7 postoperative
Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)
Time frame: baseline, workday 7 postoperative
Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).
Time frame: baseline, workday 7 postoperative
Change in Systolic bloodpressure
Time frame: baseline, workday 1 postoperative
Change in self-esteem measured by a Dutch translation of the and Rosenberg self-esteem scale (RSES)
Time frame: baseline, workday 7 postoperative
Change in Diastolic Blood pressure
Time frame: baseline, workday 1 postoperative
Temperature after surgery measured with an ear thermometer
Time frame: directly after surgery
Change in Heart Rate
Time frame: preoperatively, during surgery and postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Derived from this study: PubMed 31576513van Beek S, Kroon J, Rijs K, Mijderwijk HJ, Klimek M, Stolker RJ. The effect of midazolam as premedication on the quality of postoperative recovery after laparotomy: a randomized clinical trial. Can J Anaesth. 2020 Jan;67(1):32-41. doi: 10.1007/s12630-019-01494-6. Epub 2019 Oct 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jan Stolker, MD, PhD study chair
Erasmus MC Rotterdam Anesthesiology
Markus Klimek, MD, PhD study chair
Erasmus MC Rotterdam Anesthesiology
Stefan van Beek, BSc principal investigator
Erasmus MC Rotterdam Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam and NaCl (sodium chloride) 0,9% in people with Postoperative Period and Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Recovery (QoR-40 Scale) (time frame: baseline, workday 3 postoperative, workday 7 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01993459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.