A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
117
Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
Time frame: 0-48 hours post first study drug dose
Proportion of rescue analgesia
Time frame: Within0-24 hours and 0-48 hours after the first study drug administration
Cumulative consumption dose of rescue analgesia
Time frame: within 0-24 hours and 0-48 hours after the first study drug administration
Time from end of surgery to first passage of flatus (hours)
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
Time from end of surgery to first defecation (hours)
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Time from the end of surgery to first ambulation (hours)
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Incidence of nausea, vomiting and PONV
Time frame: Within 48 hours after the first study drug administration
Patient satisfaction score for analgesia
Time frame: Within 48 hours after the first study drug administration
Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3
Time frame: Within 0-24 hours and 0-48 hours after the first study drug administration
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Resting numerical rating scale (NRS) pain score
Time frame: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Movement-evoked numerical rating scale (NRS) pain score
Time frame: At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Incidence of rescue antiemetic treatment
Time frame: Within 48 hours after the first study drug administration
Cumulative dose of rescue antiemetic treatment
Time frame: Within 48 hours after the first study drug administration
Incidence of serious adverse events and study drug-related adverse events
Time frame: Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality)
Time frame: On the single night following the first administration of study drug
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
Time frame: Within 24 hours after the first study-drug administration
Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR)
Time frame: Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3
Time frame: Within 0-24 hours and 0-48 hours after the first study-drug administration
Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality)
Time frame: Within 48 hours after the first study-drug administration
Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)
Time frame: Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug