The Effect of Midazolam Premedication on Copeptine Concentration in Blood

Sponsor

Medical University of Warsaw (Other)

Overall Status

Completed

CT.gov ID

NCT03474939

Collaborator

(none)

Enrollment

Location

Arms

22.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Apr 3, 2017

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

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

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

Primary Outcome Measures

Change in copeptin concentration [48 hours]
Change in the concentration of copeptine measured in blood serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	I Department of Anesthesiology and Intensive Care Medical University of Warsaw	Warsaw	Mazowieckie	Poland	02-005

Sponsors and Collaborators

Medical University of Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marek Janiak, Principal Investigator, Medical University of Warsaw

ClinicalTrials.gov Identifier:

NCT03474939

Other Study ID Numbers:

MIDPRECOP

First Posted:

Mar 23, 2018

Last Update Posted:

Apr 19, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Insipidus

Midazolam

Study Results

No Results Posted as of Apr 19, 2019