RecruitingNot ApplicableNCT07375121

Comparison of the Efficacy and Safety of Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode of Intravenous PCA Following Mixed Surgery

Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode)

Sponsor

Beijing Tiantan Hospital

Enrollment

450 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Surgery Pain Management Opioid Consumption

Summary

Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

aged between 18 to 65 years;
American Society of Anesthesiologists physical status Ⅰ - Ⅲ;
Patients scheduled for elective mixed surgery were enrolled. Mixed surgeries included thoracoscopic surgery, laparoscopic surgery, hysteroscopy surgery, laparotomy, thoracotomy, open spinal surgery, craniotomy, and so on.

Exclusion Criteria3

Chronic pain syndromes;
Psychiatric disorders;
Severe cardiovascular or cerebrovascular disease, renal or hepatic functional dysfunction, or allergic to PCA medications.

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Interventions

PROCEDUREFixed-rate basal infusion mode

All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In conventional fixed-rate basal infusion mode group, the PCA was set to administer a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h.

PROCEDURETime-programmed decremental background infusion mode

The PCA settings were based on the previous study. The rate, loading dose, and demand dose of the PCA pump were all calculated based on lean body weight: Lean body weight (kg) = 0.29569 \* body weight (kg) + 0.41813 \* height (cm) - 43.2933. Loading dose (mL) = lean body weight (kg) \* 0.1 mL. Demand dose (mL) = lean body weight (kg) \* 0.04 mL. Background infusion rate within 6 hours after surgery (mL/h) = lean body weight (kg) \* 0.1 mL/h. Background infusion rate from 6 to 24 hours after surgery (mL/h) = lean body weight (kg) \* 0.02 mL/h. Background infusion rate from 24 to 48 hours after surgery (mL/h) = lean body weight (kg) \* 0.01 mL/h.