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The Effect of Midazolam Premedication on Copeptine Concentration in Blood

Primary Purpose

Preanesthetic Medication, Copeptin

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Midazolam Oral Tablet
Placebo Oral Tablet
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preanesthetic Medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • I Department of Anesthesiology and Intensive Care Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MIDAZOLAM

PLACEBO

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in copeptin concentration
Change in the concentration of copeptine measured in blood serum

Secondary Outcome Measures

Full Information

First Posted
March 16, 2018
Last Updated
April 18, 2019
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT03474939
Brief Title
The Effect of Midazolam Premedication on Copeptine Concentration in Blood
Official Title
The Effect of Midazolam Premedication on Copeptine Concentration in Blood
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preanesthetic Medication, Copeptin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIDAZOLAM
Arm Type
Active Comparator
Arm Description
Patients receive midazolam 7,5mg night before and 60 minutes prior to surgery as part of preanesthetic medication
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Patients receive 1000mg Glucose tablets night before and 60 minutes prior to surgery during premedication
Intervention Type
Drug
Intervention Name(s)
Midazolam Oral Tablet
Intervention Description
Midazolam Oral tablet
Intervention Type
Other
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Glucose 1000mg tablet night before surgery and 60 minutes before surgery
Primary Outcome Measure Information:
Title
Change in copeptin concentration
Description
Change in the concentration of copeptine measured in blood serum
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
I Department of Anesthesiology and Intensive Care Medical University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-005
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Midazolam Premedication on Copeptine Concentration in Blood

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