Dex as Analgesic Adjuvant in OSA Patients
Primary Purpose
Obstructive Sleep Apnea
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Patients scheduled for UPPP
- Patients with diagnosis of OSA via polysomnography
- American Society of Anesthesiology (ASA) classification 3 or lower
Exclusion Criteria:
- Bradycardia as defined as resting heart rate <60 Beats per min (BPM) or symptomatic
- Any degree of heart block diagnosed by ECG
- Hypotension as defined as <20% from baseline or symptomatic
- Liver failure, (two fold rise in liver enzymes)
- Chronic Kidney Disease (CKD) III or greater
- History of allergy to opioids or dexmedetomidine
- ASA classification 4 or higher
- ICU or Step down admission
- Difficult airway as defined by previous history of difficult intubation or requiring a fiberoptic intubation.
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine Sedation
Placebo
Arm Description
This group will receive 1mcg/kg bolus of dexmedetomidine over 15 minutes after intubation followed by an infusion of dexmedetomidine at 0.5mcg/kg/hr until approximately 30 minutes before the end of surgery.
This group will receive a colorless, odorless liquid (i.e. normal saline) in order to resemble Dexmedetomidine.
Outcomes
Primary Outcome Measures
Pain Score
Patient self-reported pain scores will be measured immediately after awakening post-op using the Numerical Pain Rating Scale and opioid requirements using morphine equivalents
Secondary Outcome Measures
Pain Score
Pain score and opioid requirements will continue to be measured up to 24 hours postoperatively
Nausea
participants experience of nausea will be reported
Hypoxia
Number of hypoxic events will be calculated
Length of hospital stay
Number of days spent in the hospital from admission to discharge will be assessed.
Sedation
Ramsay Sedation Scale
Time to extubation
length of time from operation to removal of endotracheal tube will be measured
Number of participants experiencing vomiting
participants' experiencing vomiting will be assessed and reported by care providers
Full Information
NCT ID
NCT03613558
First Posted
March 20, 2018
Last Updated
August 1, 2018
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03613558
Brief Title
Dex as Analgesic Adjuvant in OSA Patients
Official Title
A Double Blinded Randomized Placebo Controlled Study Evaluating the Use of Intraoperative Dexmedetomidine in Reducing Postoperative Pain and Narcotic Requirement in Patients With Moderate to Severe OSA.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit patients because the surgeon left the hospital
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess whether intravenous peri-operative Dexmedetomidine reduces opioid requirements and or improves pain control after Uvulopalatopharyngoplasty (UPPP) in patients with obstructive sleep apnea (OSA).
Detailed Description
BACKGROUND/STUDY SIGNIFICANCE
Patients with OSA undergoing surgery have increased surgical risk compared to patients that do not have OSA . Perioperative medication such as benzodiazepines and opioids can decrease upper airway tone, inhibit central respiratory drive and inhibit upper airway reflexes. The supine position may also worsen the severity of the OSA. Additionally, this group of patients is more likely to have a higher incidence of complications, particularly post operative hypoxemia , difficult intubation , and complicated extubation course .
Uvulopalatopharyngoplasty (UPPP) along with other tongue base procedures are commonly performed surgical procedures used to help alleviate the symptoms of obstructive sleep apnea (OSA). Postoperative management of oropharyngeal pain is challenging since narcotic administration may compromise respiratory status in OSA patients. The Anesthesiology and Otorhinolaryngology communities have begun to rethink acceptable narcotic use in OSA patients especially following the recent FDA announcement highlighting serious adverse effects related to codeine consumption in children who had undergone tonsillectomies.
Dexmedetomidine (Precedex) is a sedative with minimal respiratory depression. Its mechanism is via alpha 2 agonism and has 8 times the affinity for the alpha 2 adrenoreceptor than clonidine. It has been shown to have sedative, analgesic, and anxiolytic effects. It produces a predictable and dose dependent decrease in heart rate and blood pressure. Dexmedetomidine undergoes extensive metabolism in the liver and is then eliminated as methyl and glucuronide conjugates mostly via the renal system. The pharmacokinetics are markedly affected by hepatic insufficiency .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Dexmedetomidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine Sedation
Arm Type
Experimental
Arm Description
This group will receive 1mcg/kg bolus of dexmedetomidine over 15 minutes after intubation followed by an infusion of dexmedetomidine at 0.5mcg/kg/hr until approximately 30 minutes before the end of surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will receive a colorless, odorless liquid (i.e. normal saline) in order to resemble Dexmedetomidine.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine is an alpha-2 agonist that provides both sedation and analgesia
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
saline solution
Primary Outcome Measure Information:
Title
Pain Score
Description
Patient self-reported pain scores will be measured immediately after awakening post-op using the Numerical Pain Rating Scale and opioid requirements using morphine equivalents
Time Frame
within 24 hours post-operative
Secondary Outcome Measure Information:
Title
Pain Score
Description
Pain score and opioid requirements will continue to be measured up to 24 hours postoperatively
Time Frame
within 24 hours post-operative
Title
Nausea
Description
participants experience of nausea will be reported
Time Frame
within 24 hours post-operative
Title
Hypoxia
Description
Number of hypoxic events will be calculated
Time Frame
within 24 hours post-operative
Title
Length of hospital stay
Description
Number of days spent in the hospital from admission to discharge will be assessed.
Time Frame
from admission to discharge, up to 14 days
Title
Sedation
Description
Ramsay Sedation Scale
Time Frame
within 24 hours post-operative
Title
Time to extubation
Description
length of time from operation to removal of endotracheal tube will be measured
Time Frame
from post-operative until extubation, up to 72 hours
Title
Number of participants experiencing vomiting
Description
participants' experiencing vomiting will be assessed and reported by care providers
Time Frame
within 24 hours post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Patients scheduled for UPPP
Patients with diagnosis of OSA via polysomnography
American Society of Anesthesiology (ASA) classification 3 or lower
Exclusion Criteria:
Bradycardia as defined as resting heart rate <60 Beats per min (BPM) or symptomatic
Any degree of heart block diagnosed by ECG
Hypotension as defined as <20% from baseline or symptomatic
Liver failure, (two fold rise in liver enzymes)
Chronic Kidney Disease (CKD) III or greater
History of allergy to opioids or dexmedetomidine
ASA classification 4 or higher
ICU or Step down admission
Difficult airway as defined by previous history of difficult intubation or requiring a fiberoptic intubation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey Straker, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19743755
Citation
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Results Reference
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PubMed Identifier
15556378
Citation
Hillman DR, Loadsman JA, Platt PR, Eastwood PR. Obstructive sleep apnoea and anaesthesia. Sleep Med Rev. 2004 Dec;8(6):459-71. doi: 10.1016/j.smrv.2004.07.002.
Results Reference
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PubMed Identifier
21868464
Citation
Kaw R, Pasupuleti V, Walker E, Ramaswamy A, Foldvary-Schafer N. Postoperative complications in patients with obstructive sleep apnea. Chest. 2012 Feb;141(2):436-441. doi: 10.1378/chest.11-0283. Epub 2011 Aug 25.
Results Reference
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PubMed Identifier
12351303
Citation
Siyam MA, Benhamou D. Difficult endotracheal intubation in patients with sleep apnea syndrome. Anesth Analg. 2002 Oct;95(4):1098-102, table of contents. doi: 10.1097/00000539-200210000-00058.
Results Reference
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PubMed Identifier
1952000
Citation
Reeder MK, Goldman MD, Loh L, Muir AD, Casey KR, Gitlin DA. Postoperative obstructive sleep apnoea. Haemodynamic effects of treatment with nasal CPAP. Anaesthesia. 1991 Oct;46(10):849-53. doi: 10.1111/j.1365-2044.1991.tb09599.x.
Results Reference
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PubMed Identifier
10730549
Citation
Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.
Results Reference
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PubMed Identifier
23681143
Citation
Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5.
Results Reference
background
Citation
Berger R, Hsu JC. Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statis Sci. 1996;11:283-319
Results Reference
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Citation
American Academy of Sleep Medicine. International classification of sleep disorders, 2nd ed: Diagnostic and coding manual, American Academy of Sleep Medicine, Westchester, IL 2005.
Results Reference
background
Citation
FDA. (2012, August 15) FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. FDA.gov Retrieved August 8, 2013 from http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm#safety.
Results Reference
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Dex as Analgesic Adjuvant in OSA Patients
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