Anesthetics in Rhytidoplasty - A Comparison Study

April 6, 2015 updated by: Kristin A. Jones, Mercy Facial Plastic Surgery Center

The Use of Propofol/Ketamine Anesthesia With Bispectral Monitoring (PKA-BIS) Versus Inhalational Anesthetics in Rhytidoplasty - A Prospective, Double-blinded, Randomized Comparison Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Mercy Facial Plastic Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Drug: ketamine
Drug: propofol
Drug: glycopyrrolate
Drug: clonidine
Drug: lidocaine
Drug: marcaine
Other: 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)
Drug: sevoflurane
Drug: midazolam
Drug: glycopyrrolate
Drug: clonidine
Drug: metoclopramide
Drug: lidocaine
Drug: marcaine
Drug: scopolamine
Device: ondansetron
Drug: famotidine
Drug: desflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week
Nausea/vomiting (QOR-40)
Time Frame: 24 hours
Quality of recovery score (QOR-40) in PACU and POD#1
24 hours
Time to awakening
Time Frame: 4 hours
staff recorded
4 hours
Time to discharge
Time Frame: 4 hours
staff recorded
4 hours
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost (reported as a mean)
Time Frame: 1 day
comparison between two groups (reported as a mean)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Facial Plastic Surgery Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MercyFPSC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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