Dex as Analgesic Adjuvant in OSA Patients

Obstructive Sleep Apnea Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03613558
• Other study ID #: 13-10-168
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 .

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine is an alpha-2 agonist that provides both sedation and analgesia
• Placebo
saline solution

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

American Academy of Sleep Medicine. International classification of sleep disorders, 2nd ed: Diagnostic and coding manual, American Academy of Sleep Medicine, Westchester, IL 2005.

Berger R, Hsu JC. Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statis Sci. 1996;11:283-319

Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. — View 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. — View 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.

Hillman DR, Loadsman JA, Platt PR, Eastwood PR. Obstructive sleep apnoea and anaesthesia. Sleep Med Rev. 2004 Dec;8(6):459-71. Review. — View 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. — View 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. — View 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. — View Citation

Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 24 hours post-operative
Secondary	Pain Score	Pain score and opioid requirements will continue to be measured up to 24 hours postoperatively	within 24 hours post-operative
Secondary	Nausea	participants experience of nausea will be reported	within 24 hours post-operative
Secondary	Hypoxia	Number of hypoxic events will be calculated	within 24 hours post-operative
Secondary	Length of hospital stay	Number of days spent in the hospital from admission to discharge will be assessed.	from admission to discharge, up to 14 days
Secondary	Sedation	Ramsay Sedation Scale	within 24 hours post-operative
Secondary	Time to extubation	length of time from operation to removal of endotracheal tube will be measured	from post-operative until extubation, up to 72 hours
Secondary	Number of participants experiencing vomiting	participants' experiencing vomiting will be assessed and reported by care providers	within 24 hours post-operative