Dex as Analgesic Adjuvant in OSA Patients

NCT03613558 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 13-10-168
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea

Keywords

Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain Score

  within 24 hours post-operative

• Nausea

  within 24 hours post-operative

• Hypoxia

  within 24 hours post-operative

• Length of hospital stay

  from admission to discharge, up to 14 days

• Sedation

  within 24 hours post-operative

Study Arms (2)

Dexmedetomidine Sedation

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

This group will receive a colorless, odorless liquid (i.e. normal saline) in order to resemble Dexmedetomidine.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine is an alpha-2 agonist that provides both sedation and analgesia

Also known as: Precedex

Dexmedetomidine Sedation

Placebo DRUG

saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Patients scheduled for UPPP
• Patients with diagnosis of OSA via polysomnography
• American Society of Anesthesiology (ASA) classification 3 or lower

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (10)

• 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.

  PMID: 19743755 BACKGROUND

• 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.

  PMID: 15556378 BACKGROUND

• 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.

  PMID: 21868464 BACKGROUND

• 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.

  PMID: 12351303 BACKGROUND

• 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.

  PMID: 1952000 BACKGROUND

• Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.

  PMID: 10730549 BACKGROUND

• 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.

  PMID: 23681143 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tracey Straker, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: August 3, 2018
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

US (1)