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Completed

NCT Number: NCT02410460

Anesthetics in Rhytidoplasty - A 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.

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Key information

Conditions

Rhytidoplasty

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Facial Plastic Surgery Center

Springfield, Missouri, 65804, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clonidine

Drug

Glycopyrrolate

Drug

Propofol

Drug

ketamine

Drug

marcaine

Drug

Scopolamine

Drug

midazolam

Drug

ondansetron

Device

Metoclopramide

Drug

Lidocaine

Drug

Famotidine

Drug

Desflurane

Drug

Sevoflurane

Drug

Primary outcomes

  1. 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

  2. Nausea/vomiting (QOR-40)

    Time frame: 24 hours

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

  3. Time to awakening

    Time frame: 4 hours

    staff recorded

  4. Time to discharge

    Time frame: 4 hours

    staff recorded

  5. 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

Secondary outcomes

  1. Cost (reported as a mean)

    Time frame: 1 day

    comparison between two groups (reported as a mean)

Sponsors and collaborators

Lead sponsor

Mercy Facial Plastic Surgery Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 7, 2015
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.