The Effect of Midazolam Premedication on Copeptine Concen... | NCT03474939

Studies
The Effect of Midazolam Premedication on Copeptine Concentration in Blood

NCT03474939

Sponsor

Medical University of Warsaw

Status

Completed

Last Update Posted

Apr 19, 2019Actual

Enrollment

40Actual

Phase

Phase 4

Conditions

Preanesthetic Medication
Copeptin

Interventions

Midazolam Oral Tablet
Placebo Oral Tablet

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2017Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

Mar 1, 2019Actual

First Submitted Date

Mar 16, 2018

First Submission Date that Met QC Criteria

Mar 16, 2018

First Posted Date

Mar 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2019

Last Update Posted Date

Apr 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MIDAZOLAM	Active Comparator	Patients receive midazolam 7,5mg night before and 60 minutes prior to surgery as part of preanesthetic medication	Drug: Midazolam Oral Tablet
PLACEBO	Placebo Comparator	Patients receive 1000mg Glucose tablets night before and 60 minutes prior to surgery during premedication	Other: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Midazolam Oral Tablet	Drug	Midazolam Oral tablet	MIDAZOLAM
Placebo Oral Tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in copeptin concentration	Change in the concentration of copeptine measured in blood serum	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for elective surgery
Patients with no chronić illness and considered ASA 1 by anesthesiologist
Patients with mild and controlled chronic illness considered ASA 2 by anesthesiologist

Exclusion Criteria:

Patient refusal
Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
I Department of Anesthesiology and Intensive Care Medical University of Warsaw		Warsaw	Masovian Voivodeship	02-005	Poland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003919	Diabetes Insipidus

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided