Rhytidoplasty
Conditions
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.
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)
Interventions
DRUGclonidine
DRUGglycopyrrolate
DRUGpropofol
DRUGketamine
DRUGmarcaine
DRUGscopolamine
DRUGmidazolam
DEVICEondansetron
DRUGmetoclopramide
DRUGlidocaine
DRUGfamotidine
DRUGdesflurane
DRUGsevoflurane
Sponsors
Mercy Facial Plastic Surgery Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (QOR-40/VAS) | 1 week | Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7 |
| Nausea/vomiting (QOR-40) | 24 hours | Quality of recovery score (QOR-40) in PACU and POD#1 |
| Time to awakening | 4 hours | staff recorded |
| Time to discharge | 4 hours | staff recorded |
| Overall feeling of well-being (QOR-40/VAS) | 1 week | Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost (reported as a mean) | 1 day | comparison between two groups (reported as a mean) |
Countries
United States
Outcome results
None listed