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Trial record 57 of 69 for:    Famotidine

Anesthetics in Rhytidoplasty - A Comparison Study

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ClinicalTrials.gov Identifier: NCT02410460
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Kristin A. Jones, Mercy Facial Plastic Surgery Center

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: lidocaine Drug: famotidine Drug: desflurane Drug: sevoflurane Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. 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

  2. Nausea/vomiting (QOR-40) [ Time Frame: 24 hours ]
    Quality of recovery score (QOR-40) in PACU and POD#1

  3. Time to awakening [ Time Frame: 4 hours ]
    staff recorded

  4. Time to discharge [ Time Frame: 4 hours ]
    staff recorded

  5. 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


Secondary Outcome Measures :
  1. Cost (reported as a mean) [ Time Frame: 1 day ]
    comparison between two groups (reported as a mean)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410460


Locations
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United States, Missouri
Mercy Facial Plastic Surgery Center
Springfield, Missouri, United States, 65804
Sponsors and Collaborators
Mercy Facial Plastic Surgery Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristin A. Jones, Principal Investigator, Mercy Facial Plastic Surgery Center
ClinicalTrials.gov Identifier: NCT02410460     History of Changes
Other Study ID Numbers: MercyFPSC
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Famotidine
Anesthetics
Lidocaine
Propofol
Ketamine
Midazolam
Sevoflurane
Desflurane
Bupivacaine
Ondansetron
Clonidine
Metoclopramide
Scopolamine
Butylscopolammonium Bromide
Glycopyrrolate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics
Anesthetics, Dissociative