NCT05005494

Brief Summary

The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 27, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

July 27, 2021

Last Update Submit

August 13, 2021

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Propofol target concentration

    The target concentration of Propofol TCI (target-control infusion) to achieve a state entropy value between 50-60

    through study completion, an average of 3 months

Secondary Outcomes (3)

  • Morphine consumption

    through study completion, an average of 3 months

  • PPI Measure

    through study completion, an average of 3 months

  • PRD Measure

    through study completion, an average of 3 months

Study Arms (2)

Magnesium sulfate IV

ACTIVE COMPARATOR

10 patients scheduled for thyroidectomy

Drug: Magnesium sulfate IV

Placebo

PLACEBO COMPARATOR

10 patients scheduled for thyroidectomy

Drug: Placebo

Interventions

Magnesium sulfate IVDRUG

Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)

Magnesium sulfate IV
PlaceboDRUG

Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)

Placebo

Eligibility Criteria

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

You may qualify if:

  • Adult \> 18 years
  • Patients of both sexes
  • Any patient scheduled for thyroidectomy at the University Hospital of Liege

You may not qualify if:

  • Heart failure with left ventricular ejection fraction \< 35
  • Renal insufficiency (clearance \< 40 mL/min)
  • Neuromuscular diseases
  • Atrioventricular block
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Liege,

Liège, 4000, Belgium

Location

Central Study Contacts

Pierre-Yves Hardy, MD

CONTACT

003242844858pyhardy@chuliege.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patient, anesthesiologist and surgeon are blinded
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Double blinded prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology Departement

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 13, 2021

Study Start

September 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)