Patient-controlled AnalgesiaNCT06000137

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

A study testing Dezocine, Sufentanil injection and Flurbiprofen in people with Patient-controlled Analgesia, run by Eye & ENT Hospital of Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age, women only
Conditions the study is for: Patient-controlled Analgesia
What is being tested?: Dezocine, Sufentanil injection and Flurbiprofen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 1 siteChina
Study dates: 10 Feb 2022to 30 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University
Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

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.

Read the 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
Being tested: Dezocine, Sufentanil injection, Flurbiprofen, Granisetron Injection
Keywords: dezocine, sufentanil, laryngectomy, patient-controlled analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DezocineDrug
dezocine for patient-controlled analgesia
Sufentanil injectionDrug
Also called sufentanil
sufentanil for patient-controlled analgesia
FlurbiprofenDrug
Flurbiprofen for patient-controlled analgesia
Granisetron InjectionDrug
Also called granisetron
granisetron has antiemetic function.

Study groups in NCT06000137
Study group	Role	What they receive
group S	Experimental	sufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg Receives: Drug: Sufentanil injection; Drug: Flurbiprofen; Drug: Granisetron Injection
group D1	Active comparator	dezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg Receives: Drug: Dezocine; Drug: Flurbiprofen; Drug: Granisetron Injection
group D2	Active comparator	dezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg Receives: Drug: Dezocine; Drug: Flurbiprofen; Drug: Granisetron Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

total
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10
Measured: from the end of the surgery to 48 hours after surgery

Secondary outcomes (11)

24 hours amount of drug
the volume of postoperative analgesic in 24 hours after the surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at the time of 48 hours after the surgery
the incidence of nausea
the incidence of nausea
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from the time when patients use postoperative analgesic to the time when patients stop to use postoperative analgesic, assessed up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 202230 Jan 2023

First posted21 Aug 2023
Study start10 Feb 2022
Primary completion14 Jan 2023
Study completion30 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Patient-controlled AnalgesiaStudies of the same condition, open and under way.
More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06000137
Sponsor's protocol ID: dezocine and sufentanil
Status last verified: Aug 2023
First submitted: 4 May 2023
Last updated: 21 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 4329172
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.
PubMed 8193445
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.
PubMed 2670517
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.
PubMed 28230181
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.
PubMed 12437765
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.
PubMed 24263237
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.
PubMed 26640403
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.
PubMed 26287536
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.
PubMed 24753745
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.
PubMed 30278544

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy
ClinicalTrials.gov ID: NCT06000137
Acronym / sponsor ID: dezocine and sufentanil
Conditions: Patient-controlled Analgesia
Keywords: dezocine, sufentanil, laryngectomy, patient-controlled analgesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
Study start: 10 Feb 2022 (actual)
Primary completion: 14 Jan 2023 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 21 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
group S	Experimental	Drug: Sufentanil injection, Drug: Flurbiprofen, Drug: Granisetron Injectionsufentanil 2μg/kg + flurbiprofen 250mg+granisetron 6mg
group D1	Active comparator	Drug: Dezocine, Drug: Flurbiprofen, Drug: Granisetron Injectiondezocine 0.5mg/kg + flurbiprofen 250mg+granisetron 6mg
group D2	Active comparator	Drug: Dezocine, Drug: Flurbiprofen, Drug: Granisetron Injectiondezocine 0.6mg/kg + flurbiprofen 250mg+granisetron 6mg

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dezocinedezocine for patient-controlled analgesia	Drug	group D1, group D2
Sufentanil injectionAlso: sufentanilsufentanil for patient-controlled analgesia	Drug	group S
FlurbiprofenFlurbiprofen for patient-controlled analgesia	Drug	group D1, group D2, group S
Granisetron InjectionAlso: granisetrongranisetron has antiemetic function.	Drug	group D1, group D2, group S

Primary outcome

total
Time frame: from the end of the surgery to 48 hours after surgery
no pain =0, mild pain =1-3, moderate pain =4-6, and severe pain =7-10

11 secondary outcomes

24 hours amount of drug
Time frame: From the time of use postoperative analgesic to the time of 24 hours after the surgery
48 hours pressing times of Patient-controlled Analgesia
Time frame: From the time of use postoperative analgesic to the time of 48 hours after the surgery
Visual Analogue Scale
Time frame: at the time of 6 hours after the surgery
Visual Analogue Scale
Time frame: at the time of 12 hours after the surgery
Visual Analogue Scale
Time frame: at the time of 24 hours after the surgery
Visual Analogue Scale
Time frame: at the time of 48 hours after the surgery
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
Background: PubMed 4329172Budliger H, Prader A, Morscher E, Fendel H. [Round table discussion on bone age]. Radiologe. 1971 Aug;11(8):296-9. No abstract available. German.
Background: PubMed 8193445Perry 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.
Background: PubMed 2670517O'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.
Background: PubMed 28230181Wang 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.
Background: PubMed 12437765Gharagozlou 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.
Background: PubMed 24263237Liu 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.
Background: PubMed 26640403Bian 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.
Background: PubMed 26287536Zhou 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.
Background: PubMed 24753745Wang 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.
Background: PubMed 30278544Zhou 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jie Li study chair

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dezocine, Sufentanil injection and Flurbiprofen in people with Patient-controlled Analgesia, run by Eye & ENT Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total (time frame: from the end of the surgery to 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06000137, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.