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

Not Applicable

Completed

• Conditions: Patient-controlled Analgesia
• Interventions: Drug: Sufentanil injection; Drug: Dezocine; Drug: Flurbiprofen; Drug: Granisetron Injection

• Registration Number: NCT06000137
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study Start: 2022-02-10
• Primary Completion: 2023-01-14
• Study Completion: 2023-01-30
• Study First Submitted: 2023-05-04
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-12
• Last Update Submitted: 2023-08-12
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group S	Granisetron Injection	sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
group D2	Flurbiprofen	dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
group D1	Granisetron Injection	dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
group D2	Granisetron Injection	dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
group S	Sufentanil injection	sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
group D2	Dezocine	dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
group D1	Dezocine	dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
group S	Flurbiprofen	sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
group D1	Flurbiprofen	dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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 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

Trial Locations

Locations (1)

Fudan University; 🇨🇳 Shanghai, Shanghai, China