Anesthetics in Rhytidoplasty - A Comparison Study

NCT ID: NCT02410460

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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)

Conditions

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Rhytidoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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)

Group Type OTHER

clonidine

Intervention Type DRUG

glycopyrrolate

Intervention Type DRUG

propofol

Intervention Type DRUG

ketamine

Intervention Type DRUG

marcaine

Intervention Type DRUG

lidocaine

Intervention Type DRUG

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)

Group Type OTHER

clonidine

Intervention Type DRUG

marcaine

Intervention Type DRUG

scopolamine

Intervention Type DRUG

midazolam

Intervention Type DRUG

ondansetron

Intervention Type DEVICE

metoclopramide

Intervention Type DRUG

glycopyrrolate

Intervention Type DRUG

lidocaine

Intervention Type DRUG

famotidine

Intervention Type DRUG

desflurane

Intervention Type DRUG

sevoflurane

Intervention Type DRUG

Interventions

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clonidine

Intervention Type DRUG

glycopyrrolate

Intervention Type DRUG

propofol

Intervention Type DRUG

ketamine

Intervention Type DRUG

marcaine

Intervention Type DRUG

scopolamine

Intervention Type DRUG

midazolam

Intervention Type DRUG

ondansetron

Intervention Type DEVICE

metoclopramide

Intervention Type DRUG

glycopyrrolate

Intervention Type DRUG

lidocaine

Intervention Type DRUG

famotidine

Intervention Type DRUG

desflurane

Intervention Type DRUG

sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mercy Facial Plastic Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Kristin A. Jones

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mercy Facial Plastic Surgery Center

Springfield, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25906190 (View on PubMed)

Other Identifiers

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MercyFPSC

Identifier Type: -

Identifier Source: org_study_id

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