The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: group S sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg |
Drug: Sufentanil injection
sufentanil for patient-controlled analgesia
Other Names:
Drug: Flurbiprofen
Flurbiprofen for patient-controlled analgesia
Drug: Granisetron Injection
granisetron has antiemetic function.
Other Names:
|
| Active Comparator: group D1 dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg |
Drug: Dezocine
dezocine for patient-controlled analgesia
Drug: Flurbiprofen
Flurbiprofen for patient-controlled analgesia
Drug: Granisetron Injection
granisetron has antiemetic function.
Other Names:
|
| Active Comparator: group D2 dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg |
Drug: Dezocine
dezocine for patient-controlled analgesia
Drug: Flurbiprofen
Flurbiprofen for patient-controlled analgesia
Drug: Granisetron Injection
granisetron has antiemetic function.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- total [from the end of the surgery to 48 hours after surgery]
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Secondary Outcome Measures
- 24 hours amount of drug [From the time of use postoperative analgesic to the time of 24 hours after the surgery]
the volume of postoperative analgesic in 24 hours after the surgery
- 48 hours pressing times of Patient-controlled Analgesia [From the time of use postoperative analgesic to the time of 48 hours after the surgery]
the times of press analgesia pump in 24 hours after the surgery
- Visual Analogue Scale [at the time of 6 hours after the surgery]
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
- Visual Analogue Scale [at the time of 12 hours after the surgery]
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
- Visual Analogue Scale [at the time of 24 hours after the surgery]
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
- Visual Analogue Scale [at the time of 48 hours after the surgery]
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
- 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 nausea
- 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 vomiting
- 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 dizziness
- 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 urinary
- 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]
the incidence of respiratory depression
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who underwent elective partial laryngectomy
-
American society of Anesthesiologists (ASA) physical status classification :Ⅰ~Ⅱ
Exclusion Criteria:
-
chronic pain
-
long-term use of analgesics
-
allergy to perioperative medications
-
previous postoperative nausea and vomiting
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
Investigators
- Study Chair: Jie Li, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
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- 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.
- 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.
- 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.
- dezocine and sufentanil