A Phase 3 interventional study of sufentanil + nalbuphine and Sufentanil in Gastrointestinal Surgery, sponsored by Xijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by Xijing Hospital · Phase 3, Interventional, and Treatment
Objective To evaluate the effect of patient-controlled intravenous analgesia combined with different opioid receptors for gastrointestinal surgery. Methods A total of 4342 patients who underwent gastrointestinal postoperative analgesia in the first affiliated Hospital of Air Force military Medical University from May 2018 to March 2022 were collected retrospectively. The patient-controlled intravenous analgesia regimen in this study was composed of different opioid receptor drugs：sufentanil combined with nalbuphine group (SN group) and Hydromorphone combined with nalbuphine group (HN group) and single opioid receptor group: sufentanil group (S group). SN group ,HN group and S group were treated with sufentanil 100 μ g + nalbuphine 40 mg, hydromorphone 10 mg+ nalbuphine 40 mg, sufentanil 200 μ g, diluted to 100 ml, background dose 1 ml/h, PCA dose 0.5 ml, locking time 10 min. The demographic data of the three groups were collected, the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected, evaluate the analgesic effect of combination of different opioid receptor drugs and single opioid receptor drugs in PCIA after gastrointestinal surgery.
Control group：S group Test group：SN group and HN group Observation index：the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions（drowsiness, nausea and vomiting, respiratory depression, dizziness） at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected
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Exclusion Criteria:
sufentanil 100 μ g + nalbuphine 40 mg
Drug: sufentanil + nalbuphine
hydromorphone 10 mg+ nalbuphine 40 mg
Drug: hydromorphone + nalbuphine
sufentanil 200 μ g,
Drug: Sufentanil
sufentanil 100 μ g + nalbuphine 40 mg
sufentanil 200 μ g
hydromorphone 10 mg+ nalbuphine 40 mg
the incidence of insufficient static and dynamic analgesia dynamic analgesia
VAS ≥ 4
Time frame: 24 hours after operation
the incidence of insufficient static and dynamic analgesia dynamic analgesia
VAS ≥ 4
Time frame: 48 hours after operation
the incidence of adverse reactions
dizziness, nausea and vomiting
Time frame: 24 hours after operation
the incidence of adverse reactions
dizziness, nausea and vomiting
Time frame: 48 hours after operation
first exhaust time
first exhaust time
Time frame: immediately after operation
first ambulation time
first ambulation time
Time frame: immediately after operation
Plan to share: No
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Xijing Hospital