Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia
Condition: Body Temperature Changes; Anesthesia
MeSH terms: Body Temperature Changes
Study type: Interventional

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 description: 
      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 degrees Celsius (ºC). Patients will be warmed with a underbody forced-air
      blanket (BairHuggerTM3MTM) set at 38ºC and maximal flow, initiated after performing the
      neuraxial block and stopped right before leaving the operating room.

      Data will be analyzed with the Statistical Package for the Social Sciences (SPSS) program.
    

Intervention name(s): Midazolam; Propofol; Standard; SpotOn
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): The investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.; 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.; 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
Other intervention name(s): A; B
Intervention MeSH terms: Midazolam; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care