RhytidoplastyNCT02410460
Anesthetics in Rhytidoplasty - A Comparison Study
A study testing clonidine, glycopyrrolate and propofol in people with Rhytidoplasty, run by Mercy Facial Plastic Surgery Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rhytidoplasty
- What is being tested?
- clonidine, glycopyrrolate and propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 18 years of age or older
- Undergoing elective rhytidoplasty
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mercy Facial Plastic Surgery Center
Springfield, Missouri, 65804
About this study
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
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.
Read the 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)
- Conditions
- Rhytidoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidineDrug
glycopyrrolateDrug
propofolDrug
ketamineDrug
marcaineDrug
scopolamineDrug
midazolamDrug
ondansetronDevice
metoclopramideDrug
glycopyrrolateDrug
lidocaineDrug
famotidineDrug
desfluraneDrug
sevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| PKA-BIS (intravenous anesthesia) | Other | 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) Receives: Drug: clonidine; Drug: glycopyrrolate; Drug: propofol; Drug: ketamine; Drug: marcaine; Drug: lidocaine |
| Inhalational anesthesia | Other | 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) Receives: Drug: clonidine; Drug: marcaine; Drug: scopolamine; Drug: midazolam; Device: ondansetron; Drug: metoclopramide; Drug: glycopyrrolate; Drug: lidocaine; Drug: famotidine; Drug: desflurane; Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (QOR-40/VAS)
Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7
Measured: 1 week
Nausea/vomiting (QOR-40)
Quality of recovery score (QOR-40) in PACU and POD#1
Measured: 24 hours
Time to awakening
staff recorded
Measured: 4 hours
Time to discharge
staff recorded
Measured: 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
Measured: 1 week
Secondary outcomes (1)
Cost (reported as a mean)
comparison between two groups (reported as a mean)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhytidoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Facial Plastic Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin A. Jones, Mercy Facial Plastic Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410460
- Sponsor's protocol ID
- MercyFPSC
- Status last verified
- Apr 2015
- First submitted
- 23 Feb 2015
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones KA, LaFerriere KA. Intravenous Anesthesia With Bispectral Index Monitoring vs Inhalational Anesthesia for Rhytidoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2015 Jul-Aug;17(4):239-44. doi: 10.1001/jamafacial.2015.0222.
PubMed 25906190
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02410460
- Acronym / sponsor ID
- MercyFPSC
- Conditions
- Rhytidoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mercy Facial Plastic Surgery CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PKA-BIS (intravenous anesthesia) | Other | Drug: clonidine, Drug: glycopyrrolate, Drug: propofol, Drug: ketamine, Drug: marcaine, Drug: lidocaineReceived 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) |
| Inhalational anesthesia | Other | Drug: clonidine, Drug: marcaine, Drug: scopolamine, Drug: midazolam, Device: ondansetron, Drug: metoclopramide, Drug: glycopyrrolate, Drug: lidocaine, Drug: famotidine, Drug: desflurane, Drug: sevofluraneReceived 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- 18 years of age or older
- Undergoing elective rhytidoplasty
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clonidine | Drug | Inhalational anesthesia, PKA-BIS (intravenous anesthesia) |
| glycopyrrolate | Drug | PKA-BIS (intravenous anesthesia) |
| propofol | Drug | PKA-BIS (intravenous anesthesia) |
| ketamine | Drug | PKA-BIS (intravenous anesthesia) |
| marcaine | Drug | Inhalational anesthesia, PKA-BIS (intravenous anesthesia) |
| scopolamine | Drug | Inhalational anesthesia |
| midazolam | Drug | Inhalational anesthesia |
| ondansetron | Device | Inhalational anesthesia |
| metoclopramide | Drug | Inhalational anesthesia |
| glycopyrrolate | Drug | Inhalational anesthesia |
| lidocaine | Drug | Inhalational anesthesia, PKA-BIS (intravenous anesthesia) |
| famotidine | Drug | Inhalational anesthesia |
| desflurane | Drug | Inhalational anesthesia |
| sevoflurane | Drug | Inhalational anesthesia |
Primary outcome
Pain (QOR-40/VAS)
Time frame: 1 week
Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7
Nausea/vomiting (QOR-40)
Time frame: 24 hours
Quality of recovery score (QOR-40) in PACU and POD#1
Time to awakening
Time frame: 4 hours
staff recorded
Time to discharge
Time frame: 4 hours
staff recorded
Overall feeling of well-being (QOR-40/VAS)
Time frame: 1 week
Quality of recovery score (QOR-40) in PACU and POD#1, VAS POD#1 and POD#7
1 secondary outcome
Cost (reported as a mean)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 25906190Jones KA, LaFerriere KA. Intravenous Anesthesia With Bispectral Index Monitoring vs Inhalational Anesthesia for Rhytidoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2015 Jul-Aug;17(4):239-44. doi: 10.1001/jamafacial.2015.0222.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clonidine, glycopyrrolate and propofol in people with Rhytidoplasty, run by Mercy Facial Plastic Surgery Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (QOR-40/VAS) (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.