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Completed

NCT Number: NCT02502877

Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital da Luz

Lisbon, Lisbon District, 1500-650, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for orthopedic surgery of the foot or knee
  • Indication to neuraxial anesthesia
  • Surgery duration > 30 minutes

Exclusion criteria

  • Preference for deep sedation
  • Preference for no sedation
  • Kidney failure
  • Hepatic failure
  • No signed informed consent

Treatment and study plan

midazolam

Drug

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

Other names: A

Propofol

Drug

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.

Other names: B

Standard

Drug

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).

SpotOn

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital da Luz, Portugal

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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