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.

Study Overview

• Status: Completed
• Conditions: Patient-controlled Analgesia
• Intervention / Treatment: Drug: Sufentanil injection; Drug: Flurbiprofen; Drug: Granisetron Injection; Drug: Dezocine

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group S; sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg	Drug: Sufentanil injection; sufentanil for patient-controlled analgesia; Other Names: sufentanil; Drug: Flurbiprofen; Flurbiprofen for patient-controlled analgesia; Drug: Granisetron Injection; granisetron has antiemetic function.; Other Names: granisetron
Active Comparator: group D1; dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg	Drug: Flurbiprofen; Flurbiprofen for patient-controlled analgesia; Drug: Granisetron Injection; granisetron has antiemetic function.; Other Names: granisetron; Drug: Dezocine; dezocine for patient-controlled analgesia
Active Comparator: group D2; dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg	Drug: Flurbiprofen; Flurbiprofen for patient-controlled analgesia; Drug: Granisetron Injection; granisetron has antiemetic function.; Other Names: granisetron; Drug: Dezocine; dezocine for patient-controlled analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Study Chair: Jie Li, Fudan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): January 14, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: August 12, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: sufentanil; patient-controlled analgesia; laryngectomy; dezocine
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Serotonin 5-HT3 Receptor Antagonists; Granisetron; Sufentanil; Dsuvia; Flurbiprofen; Dezocine
• Other Study ID Numbers: dezocine and sufentanil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No