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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06000137
Enrollment
129
Registered
2023-08-21
Start date
2022-02-10
Completion date
2023-01-30
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient-controlled Analgesia

Keywords

dezocine, sufentanil, laryngectomy, patient-controlled analgesia

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.

Interventions

dezocine for patient-controlled analgesia

sufentanil for patient-controlled analgesia

DRUGFlurbiprofen

Flurbiprofen for patient-controlled analgesia

granisetron has antiemetic function.

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
totalfrom the end of the surgery to 48 hours after surgeryno pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10

Secondary

MeasureTime frameDescription
48 hours pressing times of Patient-controlled AnalgesiaFrom the time of use postoperative analgesic to the time of 48 hours after the surgerythe times of press analgesia pump in 24 hours after the surgery
Visual Analogue Scaleat the time of 6 hours after the surgeryno pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
the incidence of nauseafrom the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hoursthe incidence of nausea
24 hours amount of drugFrom the time of use postoperative analgesic to the time of 24 hours after the surgerythe volume of postoperative analgesic in 24 hours after the surgery
the incidence of dizzinessfrom the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hoursthe incidence of dizziness
the incidence of urinaryfrom the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hoursthe incidence of urinary
the incidence of respiratory depressionfrom the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hoursthe incidence of respiratory depression
the incidence of vomitingfrom the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hoursthe incidence of vomiting

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026