Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-03-14 @ 8:20 AM
Study NCT ID:
NCT03613558
Status:
WITHDRAWN
Last Update Posted:
2018-08-03
First Post:
2018-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dex as Analgesic Adjuvant in OSA Patients
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
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.
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit patients because the surgeon left the hospital
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 .
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 .
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: