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This study is a prospective, single-center clinical study to evaluate the advantages, extensibility and safety of hydromorphone as an analgesic drug in ICU, and to compare it with remifentanil, a traditional sedative drug. These conclusions can guide us to understand the characteristics of analgesic drugs, carry out appropriate pain management, improve the status of ICU patients, and improve the quality of life of patients.
This study will be carried out in the Affiliated Hospital of Nantong University. It is expected that 300 ICU patients who received invasive mechanical ventilation and needed analgesia and sedation will be included. The RASS and CPOT scores of 300 patients after using hydromorphone or remifentanil were collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. The relevant medical records in clinical treatment were analyzed and studied. Each subject will be numbered and a separate medical record established.
The purpose of this prospective single-center observational clinical study is to : 1 ) evaluate the advantages, extensibility and safety of hydromorphone as an ICU analgesic ; 2 ) Compared with the traditional sedative drug remifentanil. Including gastrointestinal dysfunction, respiratory depression, sedative use, mechanical ventilation time, ICU hospitalization time, extubation failure rate, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with hydromorphone and midazolam |
| ||
| Patients treated with remifentanil and midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no-intervention | Other | no-intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| RASS score | Richmond Agitation and Sedation Scale score was used to assess the patient's calm state.The maximum value of the score table is 5 and the minimum value is - 4, indicating that the patient 's sedation level changes from ' coma ' to ' aggressive '.The higher the score, the worse the patient 's sedation depth and sedation quality. | The RASS score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment. |
| CPOT score | Critical care Pain Observation Tool score is used to evaluate the degree of pain in critically ill patients.The maximum value of the score table is 10, and the minimum value is 0.The higher the score, the more serious the pain of the patient. | The CPOT score at 5, 10, 30 minutes and 1, 2, 3, 4, 8, 12, 16, 20, 24 hours post- dose and before and after each dose adjustment. |
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Inclusion Criteria:
Exclusion Criteria:
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ICU patients undergoing invasive mechanical ventilation requiring analgesia and sedation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Yuan | Contact | 13390940060 | yxy11238@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department of Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14975049 | Background | Muellejans B, Lopez A, Cross MH, Bonome C, Morrison L, Kirkham AJ. Remifentanil versus fentanyl for analgesia based sedation to provide patient comfort in the intensive care unit: a randomized, double-blind controlled trial [ISRCTN43755713]. Crit Care. 2004 Feb;8(1):R1-R11. doi: 10.1186/cc2398. Epub 2003 Nov 20. | |
| 19227610 | Background |
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Researchers hope to study data confidentiality.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Telekes A. [The role of hydromorphone in pain killing]. Lege Artis Med. 2008 Oct;18(10):675-9. Hungarian. |
| 7538514 | Background | Hagen N, Thirlwell MP, Dhaliwal HS, Babul N, Harsanyi Z, Darke AC. Steady-state pharmacokinetics of hydromorphone and hydromorphone-3-glucuronide in cancer patients after immediate and controlled-release hydromorphone. J Clin Pharmacol. 1995 Jan;35(1):37-44. doi: 10.1002/j.1552-4604.1995.tb04743.x. |
| 12479250 | Background | Inturrisi CE. Clinical pharmacology of opioids for pain. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S3-13. doi: 10.1097/00002508-200207001-00002. |
| 9061094 | Background | Christrup LL. Morphine metabolites. Acta Anaesthesiol Scand. 1997 Jan;41(1 Pt 2):116-22. doi: 10.1111/j.1399-6576.1997.tb04625.x. |
| 19576524 | Background | Panzer O, Moitra V, Sladen RN. Pharmacology of sedative-analgesic agents: dexmedetomidine, remifentanil, ketamine, volatile anesthetics, and the role of peripheral mu antagonists. Crit Care Clin. 2009 Jul;25(3):451-69, vii. doi: 10.1016/j.ccc.2009.04.004. |
| 30113379 | Background | Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299. |
| 39403896 | Background | Lombardi RA, Pereira EM, Amaral S, Medeiros HJS, Alrayashi W. Erector spinae plane block versus intravenous opioid for analgesia in pediatric cardiac surgery: A systematic review and meta-analysis. Paediatr Anaesth. 2025 Jan;35(1):17-24. doi: 10.1111/pan.15027. Epub 2024 Oct 15. |
| 26523009 | Background | Rahu MA, Grap MJ, Ferguson P, Joseph P, Sherman S, Elswick RK Jr. Validity and sensitivity of 6 pain scales in critically ill, intubated adults. Am J Crit Care. 2015 Nov;24(6):514-23. doi: 10.4037/ajcc2015832. |
| 28877145 | Background | Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683. |
| 36881257 | Background | Bauerschmidt A, Al-Bermani T, Ali S, Bass B, Dorilio J, Rosenberg J, Al-Mufti F. Modern Sedation and Analgesia Strategies in Neurocritical Care. Curr Neurol Neurosci Rep. 2023 Apr;23(4):149-158. doi: 10.1007/s11910-023-01261-7. Epub 2023 Mar 7. |
| 23269131 | Background | Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |