Dexmedetomidine Supplemented Analgesia in Patients at High-risk of Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; Analgesia; Dexmedetomidine; High-flow Nasal Cannula; Sleep Quality
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Obstructive sleep apnea (OSA) is a common sleep disturbance that can cause intermittent
      hypoxia, hypercapnia, and sleep structure disorders. The presence of OSA is associated with
      worse outcomes after surgery including increased incidence of complications. High-flow nasal
      cannula (HFNC) therapy can improve oxygenation of OSA patients by maintaining a certain
      positive pressure in the nasopharyngeal cavity. Previous studies showed that, dexmedetomidine
      supplemented analgesia can improve sleep quality and pain relief. The investigators
      hypothesize that, for high-risk OSA patients following major non-cardiac surgery with HFNC
      therapy, dexmedetomidine supplemented analgesia can improve sleep quality. The purpose of
      this pilot randomized controlled trial is to investigate the impact of dexmedetomidine
      supplemented analgesia on sleep quality in high-risk OSA patients after major non-cardiac
      surgery.
    

Detailed description: 
      Obstructive sleep apnea (OSA) is a common sleep disturbance that can cause intermittent
      hypoxia, hypercapnia, and sleep structure disorders; the latter include prolonged sleep
      latency, shortened sleep duration, frequent wake-up, and disordered circadian rhythm. During
      the postoperative period, surgical stress, pain and the residual effects of
      sedatives/analgesics can aggravate the sleep disorder and physiological changes in OSA
      patients. The resulting consequence is increased incidence of postoperative complications.

      High-flow nasal cannula (HFNC) therapy can improve the oxygenation of OSA patients by forming
      a certain positive pressure in the nasopharyngeal cavity. Previous studies showed that HFNC
      therapy can reduce respiratory events, improve oxygenation in patients with moderate to
      severe OSA.

      Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and
      anti-anxiety properties. Unlike other sedative agents, dexmedetomidine exerts its sedative
      effects through an endogenous sleep-promoting pathway, producing a state like non-rapid eye
      movement sleep without disturbing respiration. Our previous studies shows that
      dexmedetomidine supplemented analgesia can improve sleep quality and pain relief in patients
      after surgery.

      The investigators hypothesize that, for patients at high-risk of OSA who are recovering from
      major non-cardiac surgery and receiving HFNC therapy, dexmedetomidine supplemented analgesia
      can improve sleep quality and postoperative recovery. The purpose of this pilot randomized
      controlled trial is to investigate the impact of dexmedetomidine supplemented analgesia on
      the sleep quality in high-risk OSA patients after major non-cardiac surgery.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours. The pump is established with morphine (0.5 mg/ml) and dexmedetomidine (1.25 microgram/ml), in a total volume of 160 ml normal saline, and programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate of 1 ml/h.; Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours. The pump is established with morphine (0.5 mg/ml), in a total volume of 160 ml normal saline, and programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate of 1 ml/h.
Other intervention name(s): Dexmedetomidine hydrochloride; Normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obstructive Sleep Apnea; Analgesia; Dexmedetomidine; High-flow nasal cannula; Sleep quality