Anesthetics in Rhytidoplasty - A Comparison Study

Mercy Facial Plastic Surgery Center

Status: Completed

Conditions: Rhytidoplasty

Treatments: Drug: midazolam; Drug: famotidine; Drug: sevoflurane; Drug: metoclopramide; Drug: propofol; Drug: ketamine; Drug: scopolamine; Device: ondansetron; Drug: marcaine; Drug: lidocaine; Drug: clonidine; Drug: glycopyrrolate; Drug: desflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02410460

MercyFPSC

Details and patient eligibility

About

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.

Full 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)

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

30 participants in 2 patient groups

PKA-BIS (intravenous anesthesia)

Other group

Description:

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)

Treatment:

Drug: ketamine

Drug: glycopyrrolate

Drug: glycopyrrolate

Drug: marcaine

Drug: lidocaine

Drug: clonidine

Drug: propofol

Inhalational anesthesia

Other group

Description:

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)

Treatment:

Device: ondansetron

Drug: scopolamine

Drug: glycopyrrolate

Drug: glycopyrrolate

Drug: marcaine

Drug: desflurane

Drug: lidocaine

Drug: clonidine

Drug: famotidine

Drug: sevoflurane

Drug: metoclopramide

Drug: midazolam