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The Effect of Midazolam Premedication on Copeptine Concentration in Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474939
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Marek Janiak, Medical University of Warsaw

Study Description
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Brief Summary:
The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.

Condition or disease Intervention/treatment Phase
Preanesthetic Medication Copeptin Drug: Midazolam Oral Tablet Other: Placebo Oral Tablet Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: The Effect of Midazolam Premedication on Copeptine Concentration in Blood
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: MIDAZOLAM
Patients receive midazolam 7,5mg night before and 60 minutes prior to surgery as part of preanesthetic medication
 Drug: Midazolam Oral Tablet
Midazolam Oral tablet
Placebo Comparator: PLACEBO
Patients receive 1000mg Glucose tablets night before and 60 minutes prior to surgery during premedication
 Other: Placebo Oral Tablet
Glucose 1000mg tablet night before surgery and 60 minutes before surgery


Outcome Measures
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Primary Outcome Measures :
  1. Change in copeptin concentration [ Time Frame: 48 hours ]
    Change in the concentration of copeptine measured in blood serum


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474939


Locations
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Poland
I Department of Anesthesiology and Intensive Care Medical University of Warsaw
Warsaw, Mazowieckie, Poland, 02-005
Sponsors and Collaborators
Medical University of Warsaw
More Information
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Responsible Party: Marek Janiak, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03474939    
Other Study ID Numbers: MIDPRECOP
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Insipidus
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action