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

NCT06000137 | Completed

• 1 other identifier: dezocine and sufentanil
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient-controlled Analgesia

Keywords

dezocine; sufentanil; laryngectomy; patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• total

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

  from the end of the surgery to 48 hours after surgery

Secondary Outcomes (11)

• 24 hours amount of drug

  From the time of use postoperative analgesic to the time of 24 hours after the surgery

• 48 hours pressing times of Patient-controlled Analgesia

  From the time of use postoperative analgesic to the time of 48 hours after the surgery

• Visual Analogue Scale

  at the time of 6 hours after the surgery

• Visual Analogue Scale

  at the time of 12 hours after the surgery

• Visual Analogue Scale

  at the time of 24 hours after the surgery

Study Arms (3)

group S

EXPERIMENTAL

sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg

Drug: Sufentanil injection; Drug: Flurbiprofen; Drug: Granisetron Injection

group D1

ACTIVE COMPARATOR

dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg

Drug: Dezocine; Drug: Flurbiprofen; Drug: Granisetron Injection

group D2

ACTIVE COMPARATOR

dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg

Drug: Dezocine; Drug: Flurbiprofen; Drug: Granisetron Injection

Interventions

Dezocine DRUG

dezocine for patient-controlled analgesia

group D1; group D2

Sufentanil injection DRUG

sufentanil for patient-controlled analgesia

Also known as: sufentanil

group S

Flurbiprofen DRUG

Flurbiprofen for patient-controlled analgesia

group D1; group D2; group S

Granisetron Injection DRUG

granisetron has antiemetic function.

Also known as: granisetron

group D1; group D2; group S

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent elective partial laryngectomy
• American society of Anesthesiologists (ASA) physical status classification :Ⅰ\~Ⅱ

You may not qualify if:

• chronic pain
• long-term use of analgesics
• allergy to perioperative medications
• previous postoperative nausea and vomiting

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (10)

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  PMID: 4329172 BACKGROUND

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  PMID: 8193445 BACKGROUND

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  PMID: 2670517 BACKGROUND

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  PMID: 28230181 BACKGROUND

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  PMID: 12437765 BACKGROUND

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  PMID: 24263237 BACKGROUND

• Bian X, Zhou R, Yang Y, Li P, Hang Y, Hu Y, Yang L, Wen D. Divergent Effect of Dezocine, Morphine and Sufentanil on Intestinal Motor Function in Rats. Int J Med Sci. 2015 Oct 15;12(11):848-52. doi: 10.7150/ijms.12616. eCollection 2015.

  PMID: 26640403 BACKGROUND

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  PMID: 26287536 BACKGROUND

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  PMID: 24753745 BACKGROUND

• Zhou L, Zhang Y, Sun H, Hu R, Wang J, Xu G. Effect of preemptive dezocine before general anesthesia on postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A prospective observational study. Medicine (Baltimore). 2018 Sep;97(39):e12533. doi: 10.1097/MD.0000000000012533.

  PMID: 30278544 BACKGROUND

MeSH Terms

Interventions

dezocine; Sufentanil; Flurbiprofen; Granisetron

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Azabicyclo Compounds; Aza Compounds; Indazoles; Pyrazoles; Azoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jie Li

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: August 21, 2023
• Study Start: February 10, 2022
• Primary Completion: January 14, 2023
• Study Completion: January 30, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)