About this trial
Objective: This study aimed to compare the efficacy and safety of oliceridine versus morphine and sufentanil for postoperative analgesia following elective lumbar spine surgery.
Methods: In this randomized, controlled trial, 90 patients scheduled for lumbar spine surgery were allocated in a 1:1:1 ratio to receive postoperative intravenous patient-controlled analgesia (PCIA) with either oliceridine (Group O,1.5mg oliceridine for loading dose, 0.5mg/kg oliceridine for PICA), morphine (Group M,4mg morphine for loading dose,1.5mg/kg morphine for PICA), or sufentanil (Group S,4ug sufentanil for loading dose,1.5ug/kg sufentanil for PICA). The primary outcome was the movement Visual Analogue Scale (VAS) score at 6 hours postoperatively. Secondary outcomes included resting and movement VAS scores, ramsay sation score at 0.5, 2, 6, 12, 24, and 48 hours postoperatively (excluding the motor VAS score at 6 hours postoperatively); number of PCIA demands and rescue analgesic requirements within 48 hours; hemodynamic parameters at 5, 10, 15, 30, and 60 minutes after administration of the initial loading dose. The incidence of adverse events within 48 hours postoperatively, such as nausea and vomiting, somnolence, respiratory depression, or pruritus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Lumbar spine surgery with ASA grades I-III
Aged 18-65 years
Ethically, the patient voluntarily accepted this trial and signed the informed consent form
Disqualifiers
Severe respiratory and circulatory system diseases
Nervous system disease
Mental and psychological disorders
Abnormal liver and kidney functions
Trial design
Parallel
Treatments tested in this trial
Oliceridine
Druga loading dose of 1.5 mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 oliceridine was connected with normal saline to 100 ml at a rate of 2 ml per hour
Morphine
Druga loading dose of 4 mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 mg.kg-1.h-1 morphine was connected with normal saline to 100 ml at a rate of 2 ml per hour
Sufentanil
DrugA 4 ug loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03 ug.kg-1 h-1 was connected. sufentanil was mixed with normal saline to 100 ml at a rate of 2 ml per hour
Treatment groups
Trial outcomes
Primary outcomes
the movement Visual Analogue Scale (VAS) score
Sponsors and contacts
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