Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

NCT02502877 | Completed

• 1 other identifier: HDLSpot1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Temperature Changes; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Level of sensory block, T1-12/L1-5, assessed by a blunted needle

  From 5 to 10 minutes after the performance of the neuraxial block

Study Arms (2)

Midazolam Group

OTHER

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; Drug: Standard; Device: SpotOn

Propofol group

ACTIVE COMPARATOR

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; Drug: Standard; Device: SpotOn

Interventions

Midazolam DRUG

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

Also known as: A

Midazolam Group

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.

Also known as: B

Propofol group

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).

Midazolam Group; Propofol group

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

Midazolam Group; Propofol group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital da Luz, Portugal: lead

Study Sites (1)

Hospital da Luz

Lisbon, Lisbon District, 1500-650, Portugal

Location

Related Publications (4)

• 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.

  PMID: 25603202 BACKGROUND

• 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):543-549. doi: 10.1213/ANE.0000000000000319.

  PMID: 25045862 BACKGROUND

• 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.

  PMID: 22187253 BACKGROUND

• Iden T, Horn EP, Bein B, Bohm R, Beese J, Hocker 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.

  PMID: 25693138 BACKGROUND

MeSH Terms

Conditions

Body Temperature Changes

Interventions

Midazolam; Propofol

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• João Gouveia, Dr.

  Hospital da Luz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

PT (1)