Anesthetics in Rhytidoplasty - A Comparison Study

Ketamine

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.

Intervention / Treatment

  • Clonidine (DRUG)
    N/A
  • glycopyrrolate (DRUG)
    N/A
  • Propofol (DRUG)
    N/A
  • Ketamine (DRUG)
    N/A
  • marcaine (DRUG)
    N/A
  • Scopolamine (DRUG)
    N/A
  • Midazolam (DRUG)
    N/A
  • Ondansetron (DEVICE)
    N/A
  • Metoclopramide (DRUG)
    N/A
  • Lidocaine (DRUG)
    N/A
  • famotidine (DRUG)
    N/A
  • Desflurane (DRUG)
    N/A
  • Sevoflurane (DRUG)
    N/A

Condition or Disease

  • Rhytidoplasty

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 30 (ACTUAL)
    Funded by: Other
    Allocation: Randomized

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2013
    Primary Completion: Jun 01, 2014 ACTUAL
    Completion Date: Jun 01, 2014 ACTUAL
    Study First Posted: Apr 07, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 06, 2015

    Sponsors / Collaborators

    Lead Sponsor: Mercy Facial Plastic Surgery Center
    Responsible Party: N/A

    Location

    Springfield, Missouri, USA

    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)

    Participant Groups

    • 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)

    • 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)

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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)

    Primary Outcomes

    • Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7

    • Quality of recovery score (QOR-40) in PACU and POD#1

    • staff recorded

    • staff recorded

    • Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7

    Secondary Outcomes

    • comparison between two groups (reported as a mean)

    More Details

    NCT Number: NCT02410460
    Other IDs: MercyFPSC
    Study URL: https://clinicaltrials.gov/study/NCT02410460
    Last updated: Sep 29, 2023