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Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02502877
Enrollment
27
Registered
2015-07-20
Start date
2015-07-31
Completion date
2016-03-31
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Body Temperature Changes

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 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.

Interventions

DRUGMidazolam

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

DRUGPropofol

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.

DRUGStandard

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).

DEVICESpotOn

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

Sponsors

Hospital da Luz, Portugal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean temperatureFrom entering the operating room up to cutaneous closure, an expected average of 1 to 1.5 hoursComparison between the mean temperature in the two groups

Secondary

MeasureTime frameDescription
Level of sensory block, T1-12/L1-5, assessed by a blunted needleFrom 5 to 10 minutes after the performance of the neuraxial blockTop dermatome of sensory block, evaluated with a blunt needle

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026