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Laryngeal cancer is one of the most common tumors in otolaryngology. In China, it accounts for 1-5% of all malignancies and has an incidence of 1.13 per 100,000. Surgical resection is the most important treatment for patients who are not candidates for chemoradiotherapy or refuse chemoradiotherapy. The types of surgery include total and partial laryngectomy. Patients with laryngeal cancer often face multiple physical and psychiatric changes after surgery, such as daily large sputum production accompanied by cough, cleaning care of the air incision, fatigue, and sleep disturbances. Some patients do not actively exclude secretions due to pain, and the formation of sputum plugs causes lung inflammation, which is not conducive to postoperative recovery. Good postoperative pain management is beneficial to shorten the length of hospital stay and reduce mortality. Sufentanil is most commonly used for postoperative analgesia and has good analgesic effect, but there are some adverse effects, such as dizziness, nausea and vomiting, urinary retention, skin itching, respiratory depression, etc. As a new type of analgesic, dezocine has been widely used in clinical practice with few adverse reactions to the respiratory and circulatory system, and its application to postoperative analgesia can significantly improve the immune activity. At present, there are not many studies on continuous analgesia of dezocine, mostly single-dose analgesia studies, this study for different doses of dezocine for the postoperative analgesic effect of laryngeal cancer patients, compared with the current classic opioid analgesics, to provide a new scheme for clinical medication.
Laryngeal cancer is one of the most common tumors in otolaryngology. In China, it accounts for 1-5% of all malignancies and has an incidence of 1.13 per 100,000. Surgical resection is the most important treatment for patients who are not candidates for chemoradiotherapy or refuse chemoradiotherapy. The types of surgery include total and partial laryngectomy. Patients with laryngeal cancer often face multiple physical and psychiatric changes after surgery, such as daily large sputum production accompanied by cough, cleaning care of the air incision, fatigue, and sleep disturbances. In patients with laryngeal cancer, large amounts of secretions can cause frequent coughing, even wheezing, and coughing can exacerbate the degree of postoperative pain. Some patients do not actively exclude secretions due to pain, and the formation of sputum plugs causes lung inflammation, which is not conducive to postoperative recovery. In addition, the inability to verbalize after laryngeal cancer surgery puts patients in a state of anxiety, which increases the degree of postoperative pain. Good postoperative pain management is beneficial to shorten the length of hospital stay and reduce mortality. Sufentanil is most commonly used for postoperative analgesia and has good analgesic effect, but there are some adverse effects, such as dizziness, nausea and vomiting, urinary retention, skin itching, respiratory depression, etc. As a new type of analgesic, dezocine has been widely used in clinical practice with few adverse reactions to the respiratory and circulatory system, and its application to postoperative analgesia can significantly improve the immune activity. At present, there are not many studies on continuous analgesia of dezocine, mostly single-dose analgesia studies, this study for different doses of dezocine for the postoperative analgesic effect of laryngeal cancer patients, compared with the current classic opioid analgesics, to provide a new scheme for clinical medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group S | Experimental | sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg |
|
| group D1 | Active Comparator | dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg |
|
| group D2 | Active Comparator | dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dezocine | Drug | dezocine for patient-controlled analgesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| total | no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10 | from the end of the surgery to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hours amount of drug | the volume of postoperative analgesic in 24 hours after the surgery | From the time of use postoperative analgesic to the time of 24 hours after the surgery |
| 48 hours pressing times of Patient-controlled Analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Li | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4329172 | Background | Budliger H, Prader A, Morscher E, Fendel H. [Round table discussion on bone age]. Radiologe. 1971 Aug;11(8):296-9. No abstract available. German. | |
| 8193445 | Background | Perry F, Parker RK, White PF, Clifford PA. Role of psychological factors in postoperative pain control and recovery with patient-controlled analgesia. Clin J Pain. 1994 Mar;10(1):57-63; discussion 82-5. doi: 10.1097/00002508-199403000-00008. |
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| Sufentanil injection |
| Drug |
sufentanil for patient-controlled analgesia |
|
|
| Flurbiprofen | Drug | Flurbiprofen for patient-controlled analgesia |
|
| Granisetron Injection | Drug | granisetron has antiemetic function. |
|
|
the times of press analgesia pump in 24 hours after the surgery
| From the time of use postoperative analgesic to the time of 48 hours after the surgery |
| Visual Analogue Scale | no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10 | at the time of 6 hours after the surgery |
| Visual Analogue Scale | no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10 | at the time of 12 hours after the surgery |
| Visual Analogue Scale | no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10 | at the time of 24 hours after the surgery |
| Visual Analogue Scale | no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10 | at the time of 48 hours after the surgery |
| the incidence of nausea | the incidence of nausea | from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours |
| the incidence of vomiting | the incidence of vomiting | from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours |
| the incidence of dizziness | the incidence of dizziness | from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours |
| the incidence of urinary | the incidence of urinary | from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours |
| the incidence of respiratory depression | the incidence of respiratory depression | from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours |
| 2670517 | Background | O'Brien JJ, Benfield P. Dezocine. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs. 1989 Aug;38(2):226-48. doi: 10.2165/00003495-198938020-00005. |
| 28230181 | Background | Wang YX, Mao XF, Li TF, Gong N, Zhang MZ. Dezocine exhibits antihypersensitivity activities in neuropathy through spinal mu-opioid receptor activation and norepinephrine reuptake inhibition. Sci Rep. 2017 Feb 23;7:43137. doi: 10.1038/srep43137. |
| 12437765 | Background | Gharagozlou P, Demirci H, Clark JD, Lameh J. Activation profiles of opioid ligands in HEK cells expressing delta opioid receptors. BMC Neurosci. 2002 Nov 18;3:19. doi: 10.1186/1471-2202-3-19. Epub 2002 Nov 18. |
| 24263237 | Background | Liu R, Huang XP, Yeliseev A, Xi J, Roth BL. Novel molecular targets of dezocine and their clinical implications. Anesthesiology. 2014 Mar;120(3):714-23. doi: 10.1097/ALN.0000000000000076. |
| 26640403 | Background | Bian X, Zhou R, Yang Y, Li P, Hang Y, Hu Y, Yang L, Wen D. Divergent Effect of Dezocine, Morphine and Sufentanil on Intestinal Motor Function in Rats. Int J Med Sci. 2015 Oct 15;12(11):848-52. doi: 10.7150/ijms.12616. eCollection 2015. |
| 26287536 | Background | Zhou X, Zhang C, Wang M, Yu L, Yan M. Dezocine for Preventing Postoperative Pain: A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Aug 19;10(8):e0136091. doi: 10.1371/journal.pone.0136091. eCollection 2015. |
| 24753745 | Background | Wang C, Li L, Shen B, Jiang H, Yuan L, Shi D, Zhu J, Guo X, Li H. A multicenter randomized double-blind prospective study of the postoperative patient controlled intravenous analgesia effects of dezocine in elderly patients. Int J Clin Exp Med. 2014 Mar 15;7(3):530-9. eCollection 2014. |
| 30278544 | Background | Zhou L, Zhang Y, Sun H, Hu R, Wang J, Xu G. Effect of preemptive dezocine before general anesthesia on postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A prospective observational study. Medicine (Baltimore). 2018 Sep;97(39):e12533. doi: 10.1097/MD.0000000000012533. |
| ID | Term |
|---|---|
| C010827 | dezocine |
| D017409 | Sufentanil |
| D005480 | Flurbiprofen |
| D017829 | Granisetron |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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