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Trial record 16 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetes Insipidus"

The Effect of MIDazolam PREmedication on COPeptine Concentration in Blood

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ClinicalTrials.gov Identifier: NCT03474939
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Marek Janiak, Medical University of Warsaw

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


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




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



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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)

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


Contacts
Contact: Marek Janiak, MD 0048225021724 mjaniak8@gmail.com

Locations
Poland
I Department of Anesthesiology and Intensive Care Medical University of Warsaw Recruiting
Warsaw, Mazowieckie, Poland, 02-005
Contact: Marek Janiak, MD    0048225021724    klinanest1@wum.edu.pl   
Principal Investigator: Maryla Śmietanowska, MD         
Sub-Investigator: Rafał Kowalczyk, MD         
Sub-Investigator: Marek Janiak, MD         
Sponsors and Collaborators
Medical University of Warsaw

Responsible Party: Marek Janiak, MD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03474939     History of Changes
Other Study ID Numbers: MIDPRECOP
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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