Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Anesthesia Clinical Trial

Official title:

Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502877
• Other study ID #: HDLSpot1
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: April 5, 2016
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Hospital da Luz, Portugal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia
• Body Temperature Changes

Intervention

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

Locations

Country	Name	City	State
Portugal	Hospital da Luz	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Hospital da Luz, Portugal

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Eshraghi Y, Nasr V, Parra-Sanchez I, Van Duren A, Botham M, Santoscoy T, Sessler DI. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014 Sep;119(3):543-9. doi: 10.1213/ANE.0000000000000319. — View Citation

Iden T, Horn EP, Bein B, Böhm R, Beese J, Höcker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232. Erratum in: Eur J Anaesthesiol. 2015 Oct;32(10):747. — View Citation

Jeong CW, Ju J, Lee DW, Lee SH, Yoon MH. Lipid-emulsion propofol less attenuates the regulation of body temperature than micro-emulsion propofol or sevoflurane in the elderly. Yonsei Med J. 2012 Jan;53(1):198-203. doi: 10.3349/ymj.2012.53.1.198. — View Citation

Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean temperature	Comparison between the mean temperature in the two groups	From entering the operating room up to cutaneous closure, an expected average of 1 to 1.5 hours	No
Secondary	Level of sensory block, T1-12/L1-5, assessed by a blunted needle	Top dermatome of sensory block, evaluated with a blunt needle	From 5 to 10 minutes after the performance of the neuraxial block	No