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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clonidine | Drug |
| ||
| glycopyrrolate |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost (reported as a mean) | comparison between two groups (reported as a mean) | 1 day |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Facial Plastic Surgery Center | Springfield | Missouri | 65804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25906190 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2016 | |
| Reset | Apr 11, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2016 | Apr 11, 2016 |
| ID | Term |
|---|---|
| D003000 | Clonidine |
| D006024 | Glycopyrrolate |
| D015742 | Propofol |
| D007649 | Ketamine |
| D002045 | Bupivacaine |
| D012601 | Scopolamine |
| D008874 | Midazolam |
| D008787 | Metoclopramide |
| D008012 | Lidocaine |
| D015738 | Famotidine |
| D000077335 | Desflurane |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
|
| propofol | Drug |
|
| ketamine | Drug |
|
| marcaine | Drug |
|
| scopolamine | Drug |
|
| midazolam | Drug |
|
| ondansetron | Device |
|
| metoclopramide | Drug |
|
| glycopyrrolate | Drug |
|
| lidocaine | Drug |
|
| famotidine | Drug |
|
| desflurane | Drug |
|
| sevoflurane | Drug |
|
| D006571 |
| Heterocyclic Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001549 | Benzamides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D010647 | Phenyl Ethers |
| D000083 | Acetanilides |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |