Anesthetics in Rhytidoplasty - A Comparison Study

Sponsor

Mercy Facial Plastic Surgery Center (Other)

Overall Status

Completed

CT.gov ID

NCT02410460

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhytidoplasty	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	N/A

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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)	Drug: clonidine Drug: glycopyrrolate Drug: propofol Drug: ketamine Drug: marcaine Drug: lidocaine
Other: 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)	Drug: clonidine Drug: marcaine Drug: scopolamine Drug: midazolam Device: ondansetron Drug: metoclopramide Drug: glycopyrrolate Drug: lidocaine Drug: famotidine Drug: desflurane Drug: sevoflurane

Arm

Intervention/Treatment

Other: 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)

Drug: clonidine

Drug: glycopyrrolate

Drug: propofol

Drug: ketamine

Drug: marcaine

Drug: lidocaine

Other: 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)

Drug: clonidine

Drug: marcaine

Drug: scopolamine

Drug: midazolam

Device: ondansetron

Drug: metoclopramide

Drug: glycopyrrolate

Drug: lidocaine

Drug: famotidine

Drug: desflurane

Drug: sevoflurane

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Cost (reported as a mean) [1 day]
comparison between two groups (reported as a mean)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)