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Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

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ClinicalTrials.gov Identifier: NCT02502877
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
João Pedro Gouveia, Hospital da Luz, Portugal

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.

Condition or disease Intervention/treatment Phase
Body Temperature Changes Anesthesia Drug: Midazolam Drug: Propofol Drug: Standard Device: SpotOn Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia
Study Start Date : July 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Midazolam 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.
Drug: Midazolam
The investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.
Other Name: A

Drug: Standard
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).

Device: SpotOn
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

Active Comparator: Propofol group
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 TCI pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.
Drug: Propofol
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 Name: B

Drug: Standard
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).

Device: SpotOn
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502877


Locations
Portugal
Hospital da Luz
Lisboa, Portugal, 1500-650
Sponsors and Collaborators
Hospital da Luz, Portugal
Investigators
Principal Investigator: João Gouveia, Dr. Hospital da Luz

Publications:
Responsible Party: João Pedro Gouveia, Dr., Hospital da Luz, Portugal
ClinicalTrials.gov Identifier: NCT02502877     History of Changes
Other Study ID Numbers: HDLSpot1
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms
Propofol
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action