CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Midazolam +3 moredrug
Likely dose
Midazolam 0,05mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02502877
NCT02502877N/ACompleted

Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Hospital da Luz, Portugal·interventional·Posted Jul 20, 2015·Updated Apr 6, 2016

In Brief

A clinical study evaluating Midazolam, Propofol, and 2 other interventions for Body Temperature Changes and Anesthesia. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The present study is a pilot study aiming to compare the variation in core temperature (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to neuraxial anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 20, 2015
Enrollment StartJul 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.0 years ago

Interventions

Midazolamdrug

The investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.

Propofoldrug

The investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol TCI pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.

Standarddrug

The investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30 minutes before the end of surgery).

SpotOndevice

Central temperature will be monitored with the SpotOnTM3MTM device from entering till leaving the operating room, through a sensor placed in the patient's forehead