Skip to main content
OpenTrials
Completed

NCT Number: NCT06000137

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient-Controlled Analgesia

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dezocine

Drug

dezocine for patient-controlled analgesia

Sufentanil injection

Drug

sufentanil for patient-controlled analgesia

Other names: sufentanil

Flurbiprofen

Drug

Flurbiprofen for patient-controlled analgesia

Granisetron Injection

Drug

granisetron has antiemetic function.

Other names: granisetron

Primary outcomes

  1. total

    Time frame: 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 outcomes

  1. 24 hours amount of drug

    Time frame: 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

  2. 48 hours pressing times of Patient-controlled Analgesia

    Time frame: 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

  3. Visual Analogue Scale

    Time frame: at the time of 6 hours after the surgery

    no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10

  4. Visual Analogue Scale

    Time frame: at the time of 12 hours after the surgery

    no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10

  5. Visual Analogue Scale

    Time frame: at the time of 24 hours after the surgery

    no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10

  6. Visual Analogue Scale

    Time frame: 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

  7. the incidence of nausea

    Time frame: 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

  8. the incidence of vomiting

    Time frame: 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

  9. the incidence of dizziness

    Time frame: 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

  10. the incidence of urinary

    Time frame: 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

  11. the incidence of respiratory depression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.