RehabilitationPhase 4NCT06439368
Effect of Dezocine Combined With Sufentanil on the Quality of Postoperative Recovery and Analgesic Effect in Patients Undergoing Thoracic Surgery
A Phase 4 study testing Dezocine in people with Rehabilitation and Postoperative Pain, run by Yangtze River Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effect of dezocine combined with sufentanil on postoperative recovery quality and analgesic effect in patients undergoing thoracic surgery. It will also learn about the safety of dezocine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rehabilitation, Postoperative Pain
- What is being tested?
- Dezocine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2023to 31 Dec 2024
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective thoracoscopic surgery under general anesthesia, and patients with moderate to severe pain requiring opioids or opioid-non-opioids combined analgesia after surgery as assessed by the investigator;
- 18 to 65 years of age, male or female;
- Body mass index (BMI) between 18-30 kg/m ² (BMI = body weight (kg)/height ² (m ²)), including borderline values;
- Modified Mahalanobis score < III;
- ASA grade I ~ III;
- Voluntarily signed informed consent.
Who cannot join
- Inability to understand the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, or inability to understand the study procedures and pain-related assessment methods;
- Patients who cannot accept the postoperative analgesia specified in the protocol;
- Clinician judgment: liver and kidney dysfunction has clinical significance (ALT and AST > 2 times the upper limit of normal; BUN and/or Urea > 2 times the upper limit of normal, Cr > 2 times the upper limit of normal; dialysis treatment within 28 days before surgery), or coagulation dysfunction has clinical significance (PT or APTT or TT > the upper limit of normal), or poor blood pressure control (sitting SBP > 160 mmHg or SBP < 90 mmHg), or oxygen saturation (without oxygen) < 94%;
- Patients with high risk of respiratory depression or respiratory depression (such as sleep apnea syndrome);
- Patients who are allergic to the test drugs (dezocine, sufentanil);
- History of bronchial asthma;
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- Patients with hypothyroidism;
- Patients with uncontrolled gastrointestinal ulcers, gastrointestinal bleeding or perforation before surgery; or patients with paralytic ileus;
- Patients with chronic (continuous 3 months or intermittent up to 6 months) pain associated with non-surgical sites;
- Craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, cerebrovascular accident history or suffering from central nervous system diseases (such as epilepsy);
- Suffering from mental system diseases (such as depression), or long-term use of psychotropic drugs;
- Patients who cannot evaluate the pain intensity after surgery or are transferred to ICU;
- Evidence of severe cardiac dysfunction (NYHA class III and IV), unstable angina pectoris or acute myocardial infarction within 6 months before enrollment;
- Estimated operative blood loss greater than 1000 ml or other serious complications during surgery;
- Patients with a history of drug abuse, drug abuse and alcohol abuse within 2 years before the start of the screening period; Alcohol abuse was defined as regular consumption of more than 14 drinks/week (1 drink = 150 mL wine or 360 mL beer or 45 mL spirits);
- Patients who have been taking opioids for a long time (continuous use for 1 month or intermittent use for up to 3 months), or who are tolerant to opioids;
- Patients who have used monoamine oxidase inhibitors within 2 weeks;
- Participating in any clinical trial as a subject within 3 months;
- Pregnant or lactating women or patients with fertility plan within 6 months (including men);
- Patients who are judged unsuitable for participation by other investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou
Cai Li, +86 150 6101 9142, Licaisysu@163.com
About this study
Official title: Effect of Dezocine Combined With Sufentanil on the Quality of Postoperative Recovery and Analgesic Effect in Patients Undergoing Thoracic Surgery: a Randomized, Double-blind, Parallel-controlled, Multicenter Clinical Study
The goal of this clinical trial is to evaluate the effect of dezocine combined with sufentanil on postoperative recovery quality and analgesic effect in patients undergoing thoracic surgery. It will also learn about the safety of dezocine. Researchers will compare drug dezocine to Sufentanil to see if dezocine works to Improve postoperative pain and recovery quality for patients. Participants will undergo elective surgery and receive PCIA postoperatively，taking dezocine combine with sufentanil,or only sufentanil respectively. Visit the VAS score after connecting the analgesic pump 24h and 48h，and evaluate the Quality of Recovery
-15 score.
- Conditions
- Rehabilitation, Postoperative Pain
- Being tested
- Dezocine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DezocineDrug
Also called sufentanil
At the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | At the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. Receives: Drug: Dezocine |
| Control group | Other | At the end of the operation, sufentanil injection 3.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was immediately administered after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. Receives: Drug: Dezocine |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-15 score at 24 hours after connection to analgesic pump
QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good)
Measured: 24 hours
Secondary outcomes (5)
QoR-15 score at 48 hours after connection to analgesic pump
QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good)
Measured: 48 hours
Proportion of patients with ≥ 8 points increase in QoR-15 score from baseline at 24hours and 48hours after connection to analgesic pump
QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good)
Measured: 24 hours and 48 hours
Patient global impression of change score at 48 hours after connection to analgesia pump
Measured: 48 hours
Static NRS score at 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours after connection to analgesia pump
Measured: 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours
Number of effective compressions of analgesic pump with in 48 hours after connection of analgesic pump
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start5 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangtze River Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanfang Hospital, Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Kexuan Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439368
- Sponsor's protocol ID
- NFEC-2023-005
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dezocine Combined With Sufentanil on the Quality of Postoperative Recovery and Analgesic Effect in Patients Undergoing Thoracic Surgery: a Randomized, Double-blind, Parallel-controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06439368
- Acronym / sponsor ID
- NFEC-2023-005
- Conditions
- Rehabilitation, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Yangtze River Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanfang Hospital, Southern Medical University
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jun 2024 (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.
The goal of this clinical trial is to evaluate the effect of dezocine combined with sufentanil on postoperative recovery quality and analgesic effect in patients undergoing thoracic surgery. It will also learn about the safety of dezocine. Researchers will compare drug dezocine to Sufentanil to see if dezocine works to Improve postoperative pain and recovery quality for patients. Participants will undergo elective surgery and receive PCIA postoperatively，taking dezocine combine with sufentanil,or only sufentanil respectively. Visit the VAS score after connecting the analgesic pump 24h and 48h，and evaluate the Quality of Recovery
-15 score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: DezocineAt the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. |
| Control group | Other | Drug: DezocineAt the end of the operation, sufentanil injection 3.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was immediately administered after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing elective thoracoscopic surgery under general anesthesia, and patients with moderate to severe pain requiring opioids or opioid-non-opioids combined analgesia after surgery as assessed by the investigator;
- 18 to 65 years of age, male or female;
- Body mass index (BMI) between 18-30 kg/m ² (BMI = body weight (kg)/height ² (m ²)), including borderline values;
- Modified Mahalanobis score < III;
- ASA grade I ~ III;
Key exclusion criteria (20 listed)
- Inability to understand the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, or inability to understand the study procedures and pain-related assessment methods;
- Patients who cannot accept the postoperative analgesia specified in the protocol;
- Clinician judgment: liver and kidney dysfunction has clinical significance (ALT and AST > 2 times the upper limit of normal; BUN and/or Urea > 2 times the upper limit of normal, Cr > 2 times the upper limit of normal; dialysis treatment within 28 days before surgery), or coagulation dysfunction has clinical significance (PT or APTT or TT > the upper limit of normal), or poor blood pressure control (sitting SBP > 160 mmHg or SBP < 90 mmHg), or oxygen saturation (without oxygen) < 94%;
- Patients with high risk of respiratory depression or respiratory depression (such as sleep apnea syndrome);
- Patients who are allergic to the test drugs (dezocine, sufentanil);
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 |
|---|---|---|
| DezocineAlso: sufentanilAt the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. | Drug | Control group, Test group |
Primary outcome
QoR-15 score at 24 hours after connection to analgesic pump
Time frame: 24 hours
QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good)
5 secondary outcomes
QoR-15 score at 48 hours after connection to analgesic pump
Time frame: 48 hours
Proportion of patients with ≥ 8 points increase in QoR-15 score from baseline at 24hours and 48hours after connection to analgesic pump
Time frame: 24 hours and 48 hours
Patient global impression of change score at 48 hours after connection to analgesia pump
Time frame: 48 hours
Static NRS score at 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours after connection to analgesia pump
Time frame: 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours
Number of effective compressions of analgesic pump with in 48 hours after connection of analgesic pump
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Yes
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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.
Kexuan Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dezocine in people with Rehabilitation and Postoperative Pain, run by Yangtze River Pharmaceutical Group Co., Ltd. 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 6 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Jun 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiwei Feng (+86 181 1598 6602, fengsw@yangzijiang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 score at 24 hours after connection to analgesic pump (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2024.