Clinical trial NCT06000137: The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy
Official title: The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient-controlled Analgesia
Keywords: dezocine
sufentanil
laryngectomy
patient-controlled analgesia
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 129
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: total
timeFrame: from the end of the surgery to 48 hours after surgery
Secondary outcomes:
measure: 24 hours amount of drug
timeFrame: From the time of use postoperative analgesic to the time of 24 hours after the surgery
measure: 48 hours pressing times of Patient-controlled Analgesia
timeFrame: From the time of use postoperative analgesic to the time of 48 hours after the surgery
measure: Visual Analogue Scale
timeFrame: at the time of 6 hours after the surgery
measure: Visual Analogue Scale
timeFrame: at the time of 12 hours after the surgery
measure: Visual Analogue Scale
timeFrame: at the time of 24 hours after the surgery
measure: Visual Analogue Scale
timeFrame: at the time of 48 hours after the surgery
measure: the incidence of nausea
timeFrame: from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours
measure: the incidence of vomiting
timeFrame: from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours
measure: the incidence of dizziness
timeFrame: from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours
measure: the incidence of urinary
timeFrame: from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours
measure: the incidence of respiratory depression
timeFrame: from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jie Li
role: STUDY_CHAIR
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