NCT03474939

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

March 16, 2018

Last Update Submit

April 18, 2019

Conditions

Preanesthetic MedicationCopeptin

Outcome Measures

Primary Outcomes (1)

  • Change in copeptin concentration

    Change in the concentration of copeptine measured in blood serum

    48 hours

Study Arms (2)

MIDAZOLAM

ACTIVE COMPARATOR

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

Drug: Midazolam Oral Tablet

PLACEBO

PLACEBO COMPARATOR

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

Other: Placebo Oral Tablet

Interventions

Midazolam Oral TabletDRUG

Midazolam Oral tablet

MIDAZOLAM
Placebo Oral TabletOTHER

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

PLACEBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient refusal
  • Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I Department of Anesthesiology and Intensive Care Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-005, Poland

Location

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 23, 2018

Study Start

April 3, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)