Trials Sponsors Conditions Drugs Pricing

Conditions

Postoperative Pain Rehabilitation

Outcome Measures

Primary Outcomes (1)

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)
24 hours

Secondary Outcomes (5)

QoR-15 score at 48 hours after connection to analgesic pump
48 hours
Proportion of patients with ≥ 8 points increase in QoR-15 score from baseline at 24hours and 48hours after connection to analgesic pump
24 hours and 48 hours
Patient global impression of change score at 48 hours after connection to analgesia pump
48 hours
Static NRS score at 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours after connection to analgesia pump
2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours
Number of effective compressions of analgesic pump with in 48 hours after connection of analgesic pump
48 hours

Study Arms (2)

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.

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.

Drug: Dezocine

Interventions

DezocineDrug

Also known as: sufentanil

Control groupTest group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;
to 65 years of age, male or female;

Sponsors & Collaborators

Yangtze River Pharmaceutical Group Co., Ltd.
Industrylead
Nanfang Hospital, Southern Medical University
Othercollaborator

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangzhou, China

RECRUITING

Cai LiCONTACT+86 150 6101 9142 Licaisysu@163.com

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dezocineSufentanil

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Kexuan Liu
Nanfang Hospital, Southern Medical University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiwei Feng

CONTACT

+86 181 1598 6602 fengsw@yangzijiang.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 8, 2024

First Posted

June 3, 2024

Study Start

January 5, 2023

Actual (reported)

Primary Completion

December 31, 2024

Estimated (date passed)

You may not qualify if:

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;
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);
+5 more criteria

Effect of Dezocine Combined With Sufentanil on the Quality of Postoperative Recovery and Analgesic Effect in Patients Undergoing Thoracic Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Test group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Test group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations