Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566482
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia for Postoperative Sleep Promotion in Patients at High-risk of Obstructive Sleep Apnea A Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with obstructive sleep apnea OSA are at increased risk of developing sleep disturbances after surgery Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative analgesic and anxiolytic effects Ketamine is a noncompetitive N-methyl-d-aspartate NMDA receptor antagonist Esketamine is the S-enantiomer of racemic ketamine and twice as potent as racemic ketamine for analgesia A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve postoperative sleep quality in patients at high-risk of OSA
Detailed Description:
Obstructive sleep apnea OSA is characterized by repetitive narrowing or obstruction of the upper airway during sleep resulting in recurrent hypoxemia and hypercapnia and disordered sleep During the postoperative period the residual effects of anesthetics sedatives analgesics and muscle relaxants suppress the activation of airway muscles surgical stress pain and environmental interference further deteriorate sleep quality All these factors aggravate the pathophysiological changes in OSA patients and may lead to worse perioperative outcomes including increased respiratory and cardiac events intensive care unit ICU admission and delirium as well as prolonged length of hospital stay
Opioids are commonly used for postoperative analgesia Patients with OSA have significantly increased sensitivity to the side effects of opioids such as central respiratory depression reduced central respiratory drive and peripheral respiratory depression airway collapse Opioids themselves can also cause sleep disturbances as manifested by sleep fragmentation decreased rapid-eye-movement sleep and frequent nightmares On the other hand sleep deprivations can also lead to increased pain sensitivity and thus opioid consumption Therefore it is important to explore better postoperative analgesia to improve postoperative sleep quality of patients at high-risk of OSA
Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative analgesic and anxiolytic effects It produces sedation by activating the endogenous sleep-promoting pathway and produces a state resembling nonrapid eye movement sleep Ketamine is a noncompetitive N-methyl-d-aspartate NMDA receptor antagonist When given in sub-anaesthetic doses ketamine produces analgesic and anti-hyperalgesic effects and is recommended as a component of multimodal analgesia Esketamine is the S-enantiomer of racemic ketamine and approximately twice as potent as racemic ketamine for analgesia
A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve sleep quality in patients at high-risk of OSA after thoracic or abdominal surgery
Opioids are commonly used for postoperative analgesia Patients with OSA have significantly increased sensitivity to the side effects of opioids such as central respiratory depression reduced central respiratory drive and peripheral respiratory depression airway collapse Opioids themselves can also cause sleep disturbances as manifested by sleep fragmentation decreased rapid-eye-movement sleep and frequent nightmares On the other hand sleep deprivations can also lead to increased pain sensitivity and thus opioid consumption Therefore it is important to explore better postoperative analgesia to improve postoperative sleep quality of patients at high-risk of OSA
Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative analgesic and anxiolytic effects It produces sedation by activating the endogenous sleep-promoting pathway and produces a state resembling nonrapid eye movement sleep Ketamine is a noncompetitive N-methyl-d-aspartate NMDA receptor antagonist When given in sub-anaesthetic doses ketamine produces analgesic and anti-hyperalgesic effects and is recommended as a component of multimodal analgesia Esketamine is the S-enantiomer of racemic ketamine and approximately twice as potent as racemic ketamine for analgesia
A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve sleep quality in patients at high-risk of OSA after thoracic or abdominal surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None