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临床试验/NCT06320613
NCT06320613Unknown不适用

Effect of Using Snap-Needle Therapy in Combination With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy

Weifang Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Abdominal distention

研究概览

简要总结

The aim of this study was to investigate the effect of implementing snap-needle therapy combined with ginger paste during anesthesia recovery on the recovery of gastrointestinal function after gynecological laparoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I or II;
  • Performing gynecologic laparoscopic procedures under general anesthesia;

排除标准

  • Age ≤ 18 or ≥65;
  • The patient has a previous history of PONV, digestive disorders, etc;
  • Ulcers, infections, and skin tears at acupressure and acupuncture (snap-needle) treatment sites;
  • Patients allergic to ginger;
  • Inability to follow protocol or refusal to participant

研究组 & 干预措施

Experimental group acupuncture(snap-needle)

Active Comparator

Patients in the acupuncture group received acupuncture therapy (snap-needle therapy) for 24 hours. Results of the study were collected at six assessment periods of 0-0.5 h, 0-1 h, 1-3 h, 4-6h, 6-12 h, and 12-24 h after anesthesia. Conducted by an independent researcher.

干预措施: Acupuncture therapy (Other)

Experimental Ginger

Active Comparator

Patients in the Ginger Acupuncture Point Patch group received ginger patch therapy and the ginger patch was removed within 6h. Study results were collected at six assessment periods of 0-0.5h, 0-1h, 1-3h, 4-6h, 6-12h, and 12-24h after anesthesia. Conducted by an independent researcher.

干预措施: Ginger Acupuncture Point Patch (Other)

Experimental group Acupuncture combined with ginger

Active Comparator

Patients in the Acupuncture combined with ginger group received acupuncture treatment (snap-needle therapy) combined with ginger compresses, which were removed within 6h and snap-needles were removed after 24 hours. Study results were collected at six assessment periods of 0-0.5h, 0-1h, 1-3h, 4-6h, 6-12h, and 12-24h after anesthesia. Conducted by an independent researcher.

干预措施: Acupuncture therapy (Other)

Experimental group Acupuncture combined with ginger

Active Comparator

Patients in the Acupuncture combined with ginger group received acupuncture treatment (snap-needle therapy) combined with ginger compresses, which were removed within 6h and snap-needles were removed after 24 hours. Study results were collected at six assessment periods of 0-0.5h, 0-1h, 1-3h, 4-6h, 6-12h, and 12-24h after anesthesia. Conducted by an independent researcher.

干预措施: Ginger Acupuncture Point Patch (Other)

结局指标

主要结局

Abdominal distention

时间窗: Measured at 24 hours postoperatively.

The severity and incidence of Abdominal distention at 24 hours postoperatively.

Time to first flatus

时间窗: Approximately 24 hours after surgery.

Record the time of the first flatus. The earlier the time of first flatus, the earlier the time of recovery of gastrointestinal function.

Postoperative nausea and vomiting

时间窗: Measured at 24 hours postoperatively.

The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 24 hours postoperatively.

次要结局

  • Time to first defecation(Approximately 24 hours after surgery.)
  • Consumption of postoperative analgesic(Approximately 24 hours after surgery.)
  • Consumption of postoperative rescue antiemetic(Approximately 24 hours after surgery)
  • Postoperative pain response(Measured at 24 hours postoperatively.)

研究者

发起方
Weifang Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin Cheng

Pricipal Investigator

Weifang Medical University

研究点 (1)

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