Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2013-09-30
2014-06-30
Brief Summary
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Detailed Description
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clonidine 0.1-0.2mg glycopyrrolate 0.2mg propofol infusion titrated to BIS of 60-75 ketamine 50mg + additional ketamine not to exceed 200mg aggregate dosage throughout the case local anesthetic (lidocaine/marcaine mix)
General Anesthesia arm receives the following medications:
Pre-operatively:
Pepcid 20mg Scopolamine 1.5mg transdermal patch Versed 2mg Zofran 8mg Reglan 10mg Glycopyrrolate - dose determined by anesthesiologist
During the case, medication choices and dosing were dependent on the anesthesiologist - all general anesthesia cases received inhalational anesthetic (type of anesthetic also varied based on anesthesiologist's choice)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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PKA-BIS (intravenous anesthesia)
Received the following medications:
clonidine 0.1-0.2mg glycopyrrolate 0.2mg propofol infusion titrated to BIS of 60-75 ketamine 50mg + additional ketamine not to exceed 200mg aggregate dosage throughout the case local anesthetic (lidocaine/marcaine mix)
clonidine
glycopyrrolate
propofol
ketamine
marcaine
lidocaine
Inhalational anesthesia
Received the following:
Pre-operatively:
famotidine 20mg scopolamine 1.5mg transdermal patch midazolam 2mg ondansetron 8mg metoclopramide 10mg glycopyrrolate - dose determined by anesthesiologist
During the case, medication choices and dosing were dependent on the anesthesiologist - all general anesthesia cases received inhalational anesthetic (type of anesthetic - desfluorane vs. sevofluorane - also varied based on anesthesiologist's choice)
clonidine
marcaine
scopolamine
midazolam
ondansetron
metoclopramide
glycopyrrolate
lidocaine
famotidine
desflurane
sevoflurane
Interventions
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clonidine
glycopyrrolate
propofol
ketamine
marcaine
scopolamine
midazolam
ondansetron
metoclopramide
glycopyrrolate
lidocaine
famotidine
desflurane
sevoflurane
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Undergoing elective rhytidoplasty
Exclusion Criteria
* Under 18 years old
* Pregnant or breastfeeding
* Medically unfit to undergo surgery
* Undergoing brow-lift in conjunction with rhytidoplasty (due to the inability to properly secure the BIS monitor as it would lie within the surgical field)
18 Years
FEMALE
No
Sponsors
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Mercy Facial Plastic Surgery Center
OTHER
Responsible Party
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Kristin A. Jones
Principal Investigator
Locations
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Mercy Facial Plastic Surgery Center
Springfield, Missouri, United States
Countries
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References
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Jones KA, LaFerriere KA. Intravenous Anesthesia With Bispectral Index Monitoring vs Inhalational Anesthesia for Rhytidoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2015 Jul-Aug;17(4):239-44. doi: 10.1001/jamafacial.2015.0222.
Other Identifiers
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MercyFPSC
Identifier Type: -
Identifier Source: org_study_id
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