Anesthetics in Rhytidoplasty - A Comparison Study

NCT02410460 | Completed DMC

• 1 other identifier: MercyFPSC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhytidoplasty

Outcome Measures

Primary Outcomes (5)

• Pain (QOR-40/VAS)

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

  1 week

• Nausea/vomiting (QOR-40)

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

  24 hours

• Time to awakening

  staff recorded

  4 hours

• Time to discharge

  staff recorded

  4 hours

• Overall feeling of well-being (QOR-40/VAS)

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

  1 week

Secondary Outcomes (1)

• Cost (reported as a mean)

  1 day

Study Arms (2)

PKA-BIS (intravenous anesthesia)

OTHER

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: clonidine; Drug: glycopyrrolate; Drug: propofol; Drug: ketamine; Drug: marcaine; Drug: lidocaine

Inhalational anesthesia

OTHER

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: clonidine; Drug: marcaine; Drug: scopolamine; Drug: midazolam; Device: ondansetron; Drug: metoclopramide; Drug: glycopyrrolate; Drug: lidocaine; Drug: famotidine; Drug: desflurane; Drug: sevoflurane

Interventions

clonidine DRUG

Inhalational anesthesia; PKA-BIS (intravenous anesthesia)

glycopyrrolate DRUG

PKA-BIS (intravenous anesthesia)

propofol DRUG

PKA-BIS (intravenous anesthesia)

ketamine DRUG

PKA-BIS (intravenous anesthesia)

marcaine DRUG

Inhalational anesthesia; PKA-BIS (intravenous anesthesia)

scopolamine DRUG

Inhalational anesthesia

midazolam DRUG

Inhalational anesthesia

ondansetron DEVICE

Inhalational anesthesia

metoclopramide DRUG

Inhalational anesthesia

lidocaine DRUG

Inhalational anesthesia; PKA-BIS (intravenous anesthesia)

famotidine DRUG

Inhalational anesthesia

desflurane DRUG

Inhalational anesthesia

sevoflurane DRUG

Inhalational anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mercy Facial Plastic Surgery Center: lead

Study Sites (1)

Mercy Facial Plastic Surgery Center

Springfield, Missouri, 65804, United States

Location

Related Publications (1)

• 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.

  PMID: 25906190 DERIVED

MeSH Terms

Interventions

Clonidine; Glycopyrrolate; Propofol; Ketamine; Bupivacaine; Scopolamine; Midazolam; Metoclopramide; Lidocaine; Famotidine; Desflurane; Sevoflurane

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Anilides; Amides; Aniline Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzamides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Phenyl Ethers; Acetanilides; Thiazoles; Sulfur Compounds; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: April 7, 2015
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)