The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy

Conditions
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Patient-controlled Analgesia

Intervention / Treatment
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* Drug: Dezocine
* Drug: Sufentanil injection
* Drug: Flurbiprofen
* Drug: Granisetron Injection


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group S<br>sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg | Drug: Sufentanil injection<br>* sufentanil for patient-controlled analgesia<br>* Other names: sufentanil;Drug: Flurbiprofen<br>* Flurbiprofen for patient-controlled analgesia<br>Drug: Granisetron Injection<br>* granisetron has antiemetic function.<br>* Other names: granisetron;|
| Active Comparator: group D1<br>dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg | Drug: Dezocine<br>* dezocine for patient-controlled analgesia<br>Drug: Flurbiprofen<br>* Flurbiprofen for patient-controlled analgesia<br>Drug: Granisetron Injection<br>* granisetron has antiemetic function.<br>* Other names: granisetron;|
| Active Comparator: group D2<br>dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg | Drug: Dezocine<br>* dezocine for patient-controlled analgesia<br>Drug: Flurbiprofen<br>* Flurbiprofen for patient-controlled analgesia<br>Drug: Granisetron Injection<br>* granisetron has antiemetic function.<br>* Other names: granisetron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dezocine, sufentanil, laryngectomy, patient-controlled analgesia