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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Shiwei Feng
fengsw@yangzijiang.com
+86 181 1598 6602
Time Frame
Start Date: 2023-01-05
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 210
Treatments
Experimental: Test group
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.
Other: Control group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Nanfang Hospital, Southern Medical University
Leads: Yangtze River Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov