Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT06439368

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

Led by Yangtze River Pharmaceutical Group Co., Ltd. · Updated on 2024-06-03

210

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

Sponsors

Y

Yangtze River Pharmaceutical Group Co., Ltd.

Lead Sponsor

N

Nanfang Hospital, Southern Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective thoracoscopic surgery under general anesthesia with moderate to severe postoperative pain requiring opioids or combined analgesia
  • Age between 18 and 65 years, male or female
  • Body mass index (BMI) between 18 and 30 kg/m², including borderline values
  • Modified Mahalanobis score less than III
  • ASA grade I to III
  • Voluntarily signed informed consent
Not Eligible

You will not qualify if you...

  • Inability to understand the trial, its benefits, risks, procedures, or pain assessments
  • Inability to accept the specified postoperative analgesia
  • Significant liver or kidney dysfunction, coagulation disorders, poor blood pressure control, or low oxygen saturation
  • High risk or presence of respiratory depression such as sleep apnea syndrome
  • Allergy to dezocine or sufentanil
  • History of bronchial asthma
  • Hypothyroidism
  • Uncontrolled gastrointestinal ulcers, bleeding, perforation, or paralytic ileus before surgery
  • Chronic pain unrelated to surgery lasting 3 months continuous or up to 6 months intermittent
  • History of brain injury, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, or central nervous system diseases like epilepsy
  • Mental illnesses such as depression or long-term use of psychotropic drugs
  • Inability to evaluate postoperative pain or transfer to ICU
  • Severe cardiac dysfunction (NYHA class III or IV), unstable angina, or recent myocardial infarction within 6 months
  • Estimated blood loss over 1000 ml or serious surgical complications
  • History of drug, alcohol, or substance abuse within 2 years; alcohol abuse defined as more than 14 drinks per week
  • Long-term opioid use or opioid tolerance
  • Use of monoamine oxidase inhibitors within 2 weeks
  • Participation in another clinical trial within 3 months
  • Pregnant or lactating women or planned fertility within 6 months
  • Any other condition judged unsuitable by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Nanfang Hospital of Southern Medical University

Guangzhou, Guangzhou, China

Actively Recruiting

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Research Team

S

Shiwei Feng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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