Anesthetics in Rhytidoplasty - A Comparison Study

Study Overview
=================
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)

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

Conditions
-----------------
Rhytidoplasty

Intervention / Treatment
-----------------
* Drug: clonidine
* Drug: glycopyrrolate
* Drug: propofol
* Drug: ketamine
* Drug: marcaine
* Drug: scopolamine
* Drug: midazolam
* Device: ondansetron
* Drug: metoclopramide
* Drug: glycopyrrolate
* Drug: lidocaine
* Drug: famotidine
* Drug: desflurane
* Drug: sevoflurane


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PKA-BIS (intravenous anesthesia)<br>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<br> <br> Drug: glycopyrrolate<br> <br> Drug: propofol<br> <br> Drug: ketamine<br> <br> Drug: marcaine<br> <br> Drug: lidocaine<br> <br> |
| Other: Inhalational anesthesia<br>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<br> <br> Drug: marcaine<br> <br> Drug: scopolamine<br> <br> Drug: midazolam<br> <br> Device: ondansetron<br> <br> Drug: metoclopramide<br> <br> Drug: glycopyrrolate<br> <br> Drug: lidocaine<br> <br> Drug: famotidine<br> <br> Drug: desflurane<br> <br> Drug: sevoflurane<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost (reported as a mean) | comparison between two groups (reported as a mean) | 1 day |