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Central Temperature Variations During Midazolam vs Propofol Sedation for Loco Regional Anesthesia

Information source: Hospital da Luz, Portugal
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Body Temperature Changes; Anesthesia

Intervention: Midazolam (Drug); Propofol (Drug); Standard (Drug); SpotOn (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Hospital da Luz, Portugal

Official(s) and/or principal investigator(s):
João Gouveia, Dr., Principal Investigator, Affiliation: Hospital da Luz

Overall contact:
João Gouveia, Dr, Phone: 00351936924030, Email: joao.gouveia@hospitaldaluz.pt

Summary

The present study is a pilot study aiming to compare the variation in central temperature (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to loco regional anesthesia for orthopedic procedures, during sedation with midazolam vs propofol. There are currently no trials pertaining to the study of central temperature in locoregional anesthesia, giving the fact that till recently there was no device that could measure it non-invasively.

Clinical Details

Official title: Central Temperature Variations During Midazolam vs Propofol Sedation for Loco Regional Anesthesia

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

Primary outcome: Mean temperature

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

João Gouveia, Dr, Phone: 00351936924030, Email: joao.gouveia@hospitaldaluz.pt

Hospital da Luz, Lisboa 1500-650, Portugal; Recruiting
Cristina Pestana, Dr., Phone: 00351963042351, Email: amartins@hospitaldaluz.pt
João P Gouveia, Dr., Principal Investigator
Joana M Jones, Dr., Sub-Investigator
Cristina Pestana, Dr., Sub-Investigator
José Bismarck, Dr., Sub-Investigator
Additional Information

Related publications:

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.

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.

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.

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.

Starting date: July 2015
Last updated: July 17, 2015

Page last updated: August 20, 2015

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