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Anesthetics in Rhytidoplasty - A Comparison Study

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ClinicalTrials.gov Identifier: NCT02410460
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Kristin A. Jones, Mercy Facial Plastic Surgery Center

Tracking Information
First Submitted Date  ICMJE February 23, 2015
First Posted Date  ICMJE April 7, 2015
Last Update Posted Date April 7, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2015)
  • Pain (QOR-40/VAS) [ Time Frame: 1 week ]
    Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7
  • Nausea/vomiting (QOR-40) [ Time Frame: 24 hours ]
    Quality of recovery score (QOR-40) in PACU and POD#1
  • Time to awakening [ Time Frame: 4 hours ]
    staff recorded
  • Time to discharge [ Time Frame: 4 hours ]
    staff recorded
  • Overall feeling of well-being (QOR-40/VAS) [ Time Frame: 1 week ]
    Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2015)		 Cost (reported as a mean) [ Time Frame: 1 day ]
comparison between two groups (reported as a mean)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anesthetics in Rhytidoplasty - A Comparison Study
Official Title  ICMJE The Use of Propofol/Ketamine Anesthesia With Bispectral Monitoring (PKA-BIS) Versus Inhalational Anesthetics in Rhytidoplasty - A Prospective, Double-blinded, Randomized Comparison Study
Brief Summary This study is a prospective, double-blind, randomized comparison study of different anesthesia methods in rhytidoplasty surgery. The study is designed to determine whether post-operative side-effect profiles in patients undergoing elective cosmetic facelift surgery can be decreased through the use of propofol/ketamine anesthesia with bispectral monitoring (PKA-BIS) rather than general anesthesia, without increasing intra-operative time, side-effect profiles, or patient recall. Approximately 30 subjects undergoing facelift surgery performed by the principal investigator will participate.
Detailed Description

PKA-BIS arm receives 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)

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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Condition  ICMJE Rhytidoplasty
Intervention  ICMJE
  • Drug: clonidine
  • Drug: glycopyrrolate
  • Drug: propofol
  • Drug: ketamine
  • Drug: marcaine
  • Drug: scopolamine
  • Drug: midazolam
  • Device: ondansetron
  • Drug: metoclopramide
  • Drug: lidocaine
  • Drug: famotidine
  • Drug: desflurane
  • Drug: sevoflurane
Study Arms  ICMJE
  • 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)

    Interventions:
    • Drug: clonidine
    • Drug: glycopyrrolate
    • Drug: propofol
    • Drug: ketamine
    • Drug: marcaine
    • Drug: 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)

    Interventions:
    • Drug: clonidine
    • Drug: marcaine
    • Drug: scopolamine
    • Drug: midazolam
    • Device: ondansetron
    • Drug: metoclopramide
    • Drug: glycopyrrolate
    • Drug: lidocaine
    • Drug: famotidine
    • Drug: desflurane
    • Drug: sevoflurane
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2015)		 30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Female
  • 18 years of age or older
  • Undergoing elective rhytidoplasty

Exclusion criteria:

  • Male
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02410460
Other Study ID Numbers  ICMJE MercyFPSC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristin A. Jones, Mercy Facial Plastic Surgery Center
Study Sponsor  ICMJE Mercy Facial Plastic Surgery Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mercy Facial Plastic Surgery Center
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP