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

E

Eye & ENT Hospital of Fudan University

Status

Completed

Conditions

Patient-controlled Analgesia

Treatments

Drug: Flurbiprofen
Drug: Granisetron Injection
Drug: Sufentanil injection
Drug: Dezocine

Study type

Interventional

Funder types

Other

Identifiers

NCT06000137
dezocine and sufentanil

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

129 participants in 3 patient groups

group S
Experimental group
Description:
sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
Treatment:
Drug: Flurbiprofen
Drug: Sufentanil injection
Drug: Granisetron Injection
group D1
Active Comparator group
Description:
dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
Treatment:
Drug: Flurbiprofen
Drug: Dezocine
Drug: Granisetron Injection
group D2
Active Comparator group
Description:
dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
Treatment:
Drug: Flurbiprofen
Drug: Dezocine
Drug: Granisetron Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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