The Effect of Midazolam Premedication on Copeptine Concentration in Blood

NCT ID: NCT03474939

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-03-01

Brief Summary

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

Detailed Description

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Conditions

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Preanesthetic Medication Copeptin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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MIDAZOLAM

Patients receive midazolam 7,5mg night before and 60 minutes prior to surgery as part of preanesthetic medication

Group Type ACTIVE_COMPARATOR

Midazolam Oral Tablet

Intervention Type DRUG

Midazolam Oral tablet

PLACEBO

Patients receive 1000mg Glucose tablets night before and 60 minutes prior to surgery during premedication

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type OTHER

Glucose 1000mg tablet night before surgery and 60 minutes before surgery

Interventions

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Midazolam Oral Tablet

Midazolam Oral tablet

Intervention Type DRUG

Placebo Oral Tablet

Glucose 1000mg tablet night before surgery and 60 minutes before surgery

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Marek Janiak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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I Department of Anesthesiology and Intensive Care Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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MIDPRECOP

Identifier Type: -

Identifier Source: org_study_id

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