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

Primary Purpose

Patient-controlled Analgesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dezocine
Sufentanil injection
Flurbiprofen
Granisetron Injection
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient-controlled Analgesia focused on measuring dezocine, sufentanil, laryngectomy, patient-controlled analgesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

group S

group D1

group D2

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

24 hours amount of drug
the volume of postoperative analgesic in 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
Visual Analogue Scale
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Visual Analogue Scale
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Visual Analogue Scale
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Visual Analogue Scale
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
the incidence of nausea
the incidence of nausea
the incidence of vomiting
the incidence of vomiting
the incidence of dizziness
the incidence of dizziness
the incidence of urinary
the incidence of urinary
the incidence of respiratory depression
the incidence of respiratory depression

Full Information

First Posted
May 4, 2023
Last Updated
August 12, 2023
Sponsor
Eye & ENT Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT06000137
Brief Title
The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy
Official Title
The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
January 14, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient-controlled Analgesia
Keywords
dezocine, sufentanil, laryngectomy, patient-controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group S
Arm Type
Experimental
Arm Description
sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
Arm Title
group D1
Arm Type
Active Comparator
Arm Description
dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
Arm Title
group D2
Arm Type
Active Comparator
Arm Description
dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg
Intervention Type
Drug
Intervention Name(s)
Dezocine
Intervention Description
dezocine for patient-controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Sufentanil injection
Other Intervention Name(s)
sufentanil
Intervention Description
sufentanil for patient-controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen
Intervention Description
Flurbiprofen for patient-controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Granisetron Injection
Other Intervention Name(s)
granisetron
Intervention Description
granisetron has antiemetic function.
Primary Outcome Measure Information:
Title
total
Description
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Time Frame
from the end of the surgery to 48 hours after surgery
Secondary Outcome Measure Information:
Title
24 hours amount of drug
Description
the volume of postoperative analgesic in 24 hours after the surgery
Time Frame
From the time of use postoperative analgesic to the time of 24 hours after the surgery
Title
48 hours pressing times of Patient-controlled Analgesia
Description
the times of press analgesia pump in 24 hours after the surgery
Time Frame
From the time of use postoperative analgesic to the time of 48 hours after the surgery
Title
Visual Analogue Scale
Description
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Time Frame
at the time of 6 hours after the surgery
Title
Visual Analogue Scale
Description
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Time Frame
at the time of 12 hours after the surgery
Title
Visual Analogue Scale
Description
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Time Frame
at the time of 24 hours after the surgery
Title
Visual Analogue Scale
Description
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Time Frame
at the time of 48 hours after the surgery
Title
the incidence of nausea
Description
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
Title
the incidence of vomiting
Description
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
Title
the incidence of dizziness
Description
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
Title
the incidence of urinary
Description
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
Title
the incidence of respiratory depression
Description
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Li
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy

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