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

Patient-controlled Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06000137
• Other study ID #: dezocine and sufentanil
• Status: Completed
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: August 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 30, 2023
• Est. primary completion date: January 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who underwent elective partial laryngectomy

• American society of Anesthesiologists (ASA) physical status classification :?~?

Exclusion Criteria:

• chronic pain

• long-term use of analgesics

• allergy to perioperative medications

• previous postoperative nausea and vomiting

Related Conditions & MeSH terms

• Patient-controlled Analgesia

Intervention

Drug:
• Dezocine
dezocine for patient-controlled analgesia
• Sufentanil injection
sufentanil for patient-controlled analgesia
• Flurbiprofen
Flurbiprofen for patient-controlled analgesia
• Granisetron Injection
granisetron has antiemetic function.

Locations

Country	Name	City	State
China	Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours amount of drug	the volume of postoperative analgesic in 24 hours after the surgery	From the time of use postoperative analgesic to the time of 24 hours after the surgery
Secondary	48 hours pressing times of Patient-controlled Analgesia	the times of press analgesia pump in 24 hours after the surgery	From the time of use postoperative analgesic to the time of 48 hours after the surgery
Secondary	Visual Analogue Scale	no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10	at the time of 6 hours after the surgery
Secondary	Visual Analogue Scale	no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10	at the time of 12 hours after the surgery
Secondary	Visual Analogue Scale	no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10	at the time of 24 hours after the surgery
Secondary	Visual Analogue Scale	no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10	at the time of 48 hours after the surgery
Secondary	the incidence of nausea	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
Secondary	the incidence of vomiting	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
Secondary	the incidence of dizziness	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
Secondary	the incidence of urinary	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
Secondary	the incidence of respiratory depression	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