Expired Study
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Springfield, Missouri 65804


Purpose:

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 summary:

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)


Criteria:

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)


NCT ID:

NCT02410460


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Springfield, Missouri 65804
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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