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临床试验/NCT05576675
NCT05576675已完成3 期

Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 4,342 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
4,342
试验地点
1
主要终点
the incidence of insufficient static and dynamic analgesia dynamic analgesia

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years ,there is no gender limit,ASA grade Ⅰ-Ⅱ

排除标准

  • BMI > 35 kg/m2, history of upper abdominal surgery, history of analgesic or hormone use before operation, history of depression or chronic pain before operation, infection before operation and ICU after operation

研究组 & 干预措施

SN group

Experimental

sufentanil 100 μ g + nalbuphine 40 mg

干预措施: sufentanil + nalbuphine (Drug)

HN group

Experimental

hydromorphone 10 mg+ nalbuphine 40 mg

干预措施: hydromorphone + nalbuphine (Drug)

S group

Experimental

sufentanil 200 μ g,

干预措施: Sufentanil (Drug)

结局指标

主要结局

the incidence of insufficient static and dynamic analgesia dynamic analgesia

时间窗: 48 hours after operation

VAS ≥ 4

次要结局

  • the incidence of adverse reactions(48 hours after operation)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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