NCT01993459

Brief Summary

The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

October 29, 2013

Last Update Submit

January 24, 2016

Conditions

Postoperative PeriodAnxietyFatigueDepressionAggression

Keywords

Quality of Recovery

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Recovery (QoR-40 Scale)

    baseline, workday 3 postoperative, workday 7 postoperative

Secondary Outcomes (9)

  • Change in anxiety measured with a Dutch translated State-Trait Anxiety Inventory (STAI)

    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)

    baseline, workday 1 postoperative, workday 7 postoperative

  • Change in fatigue measured by a validated Dutch questionnaire Multidimensional Fatigue Index : "Multidimensionele Vermoeidheids Index" (MVI-20)

    baseline, workday 7 postoperative

  • Change in self-efficacy measured by a Dutch translation of General Self-Efficacy- Schwarzer (GSES).

    baseline, workday 7 postoperative

  • Change in Systolic bloodpressure

    baseline, workday 1 postoperative

  • +4 more secondary outcomes

Study Arms (2)

Midazolam intravenous

EXPERIMENTAL

3mg/ml midazolam given intravenously

Drug: Midazolam

NaCl (sodium chloride) 0,9%

PLACEBO COMPARATOR

NaCl (sodium chloride) 0,9% given intravenously 3ml.

Drug: NaCl (sodium chloride) 0,9%

Interventions

MidazolamDRUG

We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery

Also known as: Dormicum
Midazolam intravenous
NaCl (sodium chloride) 0,9%DRUG

We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery

Also known as: saline solution, sodium chloride solution
NaCl (sodium chloride) 0,9%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Centre

Rotterdam, South Holland, 3000CA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 31576513DERIVED

MeSH Terms

Conditions

Anxiety DisordersFatigueDepressionAggression

Interventions

MidazolamSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorAberrant Motor Behavior in DementiaSocial Behavior

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Robert Jan Stolker, MD, PhD

    Erasmus MC Rotterdam Anesthesiology

    STUDY CHAIR

  • Markus Klimek, MD, PhD

    Erasmus MC Rotterdam Anesthesiology

    STUDY CHAIR

  • Stefan van Beek, BSc

    Erasmus MC Rotterdam Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 25, 2013

Study Start

February 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

NL(1)