Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Patient-controlled analgesia is established with morphine (0.5 mg/ml) and dexmedetomidine (1.25 microgram/ml) in a total volume of 160 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours after surgery. |
|
| Placebo group | Placebo Comparator | Patient-controlled analgesia is established with morphine (0.5 mg/ml) in a total volume of 160 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of non-rapid eye movement stage 2 (N2) sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep duration. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Sleep efficiency. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation level | Sedation level is assessed with the Richmond Agitation Sedation Scale (RASS), with scores ranging from -5 (unarousable) to +4 (combative) and 0 indicates alert and calm. | Up to 5 days after surgery. |
| Cumulative morphine consumption |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-Xin Wang | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20086074 | Background | Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008. | |
| 31300334 | Background | Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000377 | Agnosia |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Drug | 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. |
|
|
The ratio between the total sleep time and the total recording time and expressed as percentage. Calculated according to polysomnographic monitoring results.
| During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Duration of non-rapid eye movement stage 1 (N1) sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Percentage of non-rapid eye movement stage 1 (N1) sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Duration of non-rapid eye movement stage 2 (N2) sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Duration of non-rapid eye movement stage 3 (N3) sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Percentage of non-rapid eye movement stage 3 (N3) sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Duration of rapid eye movement sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Percentage of rapid eye movement sleep. | Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
| Sleep fragmentation index. | The average number of arousals and awakenings per hour of sleep. Calculated according to polysomnographic monitoring results. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
Cumulative morphine consumption
| Up to 5 days after surgery. |
| Pain intensity | Pain intensity is assessed twice daily (8-10 am and 18-20 pm) with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain. | Up to 5 days after surgery. |
| Subjective sleep quality during the first 5 days after surgery. | Subjective sleep quality is assessed daily (8-10 am) with the Richards-Campbell Sleep Questionnaire; which assesses subjective sleep quality in 5 aspects, each scale ranges from 0 to 100, with higher score indicating better function. | Up to the fifth day after surgery. |
| Incidence of delirium during the first 5 days after surgery. | Delirium is assessed twice daily (8-10 am and 18-20 pm) with the 3D-Confusion Assessment Method for non-intubated patients or the Confusion Assessment Methods for the Intensive Care Unit for intubated patients. | Up to the fifth day after surgery. |
| Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery |
| Incidence of postoperative complications within 30 days | Postoperative complications are generally defined as newly occurred medical conditions that are deemed harmful and required therapeutic intervention within 30 days after surgery. | Up to 30 days after surgery |
| All-cause 30-day mortality | All-cause 30-day mortality | Up to 30 days after surgery |
| Quality of life in 30-day survivors | Quality of life is assessed with World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function. | At 30 days after surgery |
| Cognitive function in 30-day survivors | Cognitive function of 30-day survivors is assessed with the modified Telephone Interview for Cognitive Status (TICSm), a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 48, with higher score indicating better function. | At 30 days after surgery |
| The overall subjective sleep quality in 30-day survivors | Assessed with the Pittsburgh Sleep Quality Index, which estimates overall subjective sleep quality in the past 30 days. Overall score ranges from 0 to 21, with higher score indicating better sleep. | At 30 days after surgery |
| 23589584 | Background | Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14. |
| 19690624 | Background | Lee W, Nagubadi S, Kryger MH, Mokhlesi B. Epidemiology of Obstructive Sleep Apnea: a Population-based Perspective. Expert Rev Respir Med. 2008 Jun 1;2(3):349-364. doi: 10.1586/17476348.2.3.349. |
| 28162150 | Background | Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506. |
| 19293703 | Background | Brown KA. Intermittent hypoxia and the practice of anesthesia. Anesthesiology. 2009 Apr;110(4):922-7. doi: 10.1097/ALN.0b013e31819c480a. |
| 27476705 | Background | Fassbender P, Herbstreit F, Eikermann M, Teschler H, Peters J. Obstructive Sleep Apnea-a Perioperative Risk Factor. Dtsch Arztebl Int. 2016 Jul 11;113(27-28):463-9. doi: 10.3238/arztebl.2016.0463. |
| 21868464 | 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. |
| 18339794 | Background | Hwang D, Shakir N, Limann B, Sison C, Kalra S, Shulman L, Souza Ade C, Greenberg H. Association of sleep-disordered breathing with postoperative complications. Chest. 2008 May;133(5):1128-34. doi: 10.1378/chest.07-1488. Epub 2008 Mar 13. |
| 19774431 | Background | Liao P, Yegneswaran B, Vairavanathan S, Zilberman P, Chung F. Postoperative complications in patients with obstructive sleep apnea: a retrospective matched cohort study. Can J Anaesth. 2009 Nov;56(11):819-28. doi: 10.1007/s12630-009-9190-y. |
| 15947324 | Background | Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005 Jun;127(6):2085-93. doi: 10.1378/chest.127.6.2085. |
| 29558988 | Background | Helviz Y, Einav S. A Systematic Review of the High-flow Nasal Cannula for Adult Patients. Crit Care. 2018 Mar 20;22(1):71. doi: 10.1186/s13054-018-1990-4. |
| 17363769 | Background | McGinley BM, Patil SP, Kirkness JP, Smith PL, Schwartz AR, Schneider H. A nasal cannula can be used to treat obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Jul 15;176(2):194-200. doi: 10.1164/rccm.200609-1336OC. Epub 2007 Mar 15. |
| 28105598 | Background | Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7. |
| 27542303 | Background | Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16. |
| 29742525 | Background | Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801. |
| 26378880 | Background | Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 26289837 | Background | Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20. |
| 39416950 | Derived | Sun P, Liang XQ, Chen NP, Ma JH, Zhang C, Shen YE, Zhu SN, Wang DX. Impact of mini-dose dexmedetomidine supplemented analgesia on sleep structure in patients at high risk of obstructive sleep apnea: a pilot trial. Front Neurosci. 2024 Oct 2;18:1426729. doi: 10.3389/fnins.2024.1426729. eCollection 2024. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |