Clinical Trial: Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Brief 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.

Detailed Summary:

In this study the investigators will select 20 patients scheduled for orthopedic surgery of the knee or foot with neuraxial anesthesia (subarachnoid or sequential blocks). Sedation for these procedures with midazolam or propofol is daily practice in the investigators' department.

So the patients will be randomized, through the envelope method, in 2 groups with 10 patients each: "midazolam group" and "propofol group".

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

In the "propofol group" 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 target-controlled infusion (TCI) pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.

The neuraxial block will be performed inside the operating room and preferentially in lateral decubitus. The choice of drug and dosage used for the block will be left to the anesthesiologist, to mimetize day-to-day practice. The limit dermatome of sensory block will be noted.

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).

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. Room temperature will be kept at 17 degre
Sponsor: Hospital da Luz, Portugal

Current Primary Outcome: Mean temperature [ Time Frame: From entering the operating room up to cutaneous closure, an expected average of 1 to 1.5 hours ]

Comparison between the mean temperature in the two groups


Original Primary Outcome: Same as current

Current Secondary Outcome: Level of sensory block, T1-12/L1-5, assessed by a blunted needle [ Time Frame: From 5 to 10 minutes after the performance of the neuraxial block ]

Top dermatome of sensory block, evaluated with a blunt needle


Original Secondary Outcome: Same as current

Information By: Hospital da Luz, Portugal

Dates:
Date Received: July 8, 2015
Date Started: July 2015
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016