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

NCT ID: NCT06000137

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-01-30

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.

Conditions

Patient-controlled Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group S

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

Group Type: EXPERIMENTAL

Sufentanil injection

Intervention Type: DRUG

sufentanil for patient-controlled analgesia

Flurbiprofen

Intervention Type: DRUG

Flurbiprofen for patient-controlled analgesia

Granisetron Injection

Intervention Type: DRUG

granisetron has antiemetic function.

group D1

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

Group Type: ACTIVE_COMPARATOR

Dezocine

Intervention Type: DRUG

dezocine for patient-controlled analgesia

Flurbiprofen

Intervention Type: DRUG

Flurbiprofen for patient-controlled analgesia

Granisetron Injection

Intervention Type: DRUG

granisetron has antiemetic function.

group D2

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

Group Type: ACTIVE_COMPARATOR

Dezocine

Intervention Type: DRUG

dezocine for patient-controlled analgesia

Flurbiprofen

Intervention Type: DRUG

Flurbiprofen for patient-controlled analgesia

Granisetron Injection

Intervention Type: DRUG

granisetron has antiemetic function.

Interventions

Dezocine

dezocine for patient-controlled analgesia

Intervention Type: DRUG

Sufentanil injection

sufentanil for patient-controlled analgesia

Intervention Type: DRUG

Flurbiprofen

Flurbiprofen for patient-controlled analgesia

Intervention Type: DRUG

Granisetron Injection

granisetron has antiemetic function.

Intervention Type: DRUG

Other Intervention Names

sufentanil; granisetron

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Li

Role: STUDY_CHAIR

Fudan University

Locations

Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

Budliger H, Prader A, Morscher E, Fendel H. [Round table discussion on bone age]. Radiologe. 1971 Aug;11(8):296-9. No abstract available. German.

Reference Type: BACKGROUND

PMID: 4329172 (View on PubMed)

Perry F, Parker RK, White PF, Clifford PA. Role of psychological factors in postoperative pain control and recovery with patient-controlled analgesia. Clin J Pain. 1994 Mar;10(1):57-63; discussion 82-5. doi: 10.1097/00002508-199403000-00008.

Reference Type: BACKGROUND

PMID: 8193445 (View on PubMed)

O'Brien JJ, Benfield P. Dezocine. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs. 1989 Aug;38(2):226-48. doi: 10.2165/00003495-198938020-00005.

Reference Type: BACKGROUND

PMID: 2670517 (View on PubMed)

Wang YX, Mao XF, Li TF, Gong N, Zhang MZ. Dezocine exhibits antihypersensitivity activities in neuropathy through spinal mu-opioid receptor activation and norepinephrine reuptake inhibition. Sci Rep. 2017 Feb 23;7:43137. doi: 10.1038/srep43137.

Reference Type: BACKGROUND

PMID: 28230181 (View on PubMed)

Gharagozlou P, Demirci H, Clark JD, Lameh J. Activation profiles of opioid ligands in HEK cells expressing delta opioid receptors. BMC Neurosci. 2002 Nov 18;3:19. doi: 10.1186/1471-2202-3-19. Epub 2002 Nov 18.

Reference Type: BACKGROUND

PMID: 12437765 (View on PubMed)

Liu R, Huang XP, Yeliseev A, Xi J, Roth BL. Novel molecular targets of dezocine and their clinical implications. Anesthesiology. 2014 Mar;120(3):714-23. doi: 10.1097/ALN.0000000000000076.

Reference Type: BACKGROUND

PMID: 24263237 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26640403 (View on PubMed)

Zhou X, Zhang C, Wang M, Yu L, Yan M. Dezocine for Preventing Postoperative Pain: A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Aug 19;10(8):e0136091. doi: 10.1371/journal.pone.0136091. eCollection 2015.

Reference Type: BACKGROUND

PMID: 26287536 (View on PubMed)

Wang C, Li L, Shen B, Jiang H, Yuan L, Shi D, Zhu J, Guo X, Li H. A multicenter randomized double-blind prospective study of the postoperative patient controlled intravenous analgesia effects of dezocine in elderly patients. Int J Clin Exp Med. 2014 Mar 15;7(3):530-9. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24753745 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30278544 (View on PubMed)

Other Identifiers

dezocine and sufentanil

Identifier Type: -

Identifier Source: org_study_id