High-dose Acupuncture for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Surgery: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of patients who experience moderate or severe level nausea or vomiting
研究概览
简要总结
Background: PONV is one of the prevalent discomforts in the early phase of recovery after surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces more benefits compared with P6 stimulation alone or whether acupuncture combined with standard antiemetic medication yields better outcomes.
Objectives: This study aims to assess the effectiveness, safety, and feasibility of intensive acupuncture treatments combined with standard antiemetic medication as compared with P6 acupoint stimulation combined with standard antiemetic medication or with standard antiemetic medication alone.
详细描述
Background: PONV is one of the prevalent discomforts in the early phase of recovery after surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces more benefits compared with P6 stimulation alone or whether acupuncture combined with standard antiemetic medication yields better outcomes. This study aims to assess the effectiveness and safety of different acupuncture regimen for the prevention of PONV: high-dose acupuncture treatments combined with standard antiemetic medication, P6 acupuncture-point stimulation combined with standard antiemetic medication, or medication alone.
Objectives: This study aims to assess the effectiveness, safety, and feasibility of intensive acupuncture treatments combined with standard antiemetic medication as compared with P6 acupoint stimulation combined with standard antiemetic medication or with standard antiemetic medication alone, to prevent postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic colorectal surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective laparoscopic surgery of colorectal cancer resection (right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion)
- •Patients aged 18 to 80
- •American Society of Anesthesiologists Grade 1 to 2
- •Written informed consents
排除标准
- •Pregnancy
- •Inflammatory bowel disease
- •Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)
- •Use of emetogenic / antiemetic medication within 24 hours before surgery
- •Previous history of emetic episodes after administration of antibiotics
- •Expected use of mechanical ventilation
- •Cognitive impairment that may affect the patient's ability to complete the outcome assessments
- •Previous history of stroke
- •Previous history of sensitive reaction to acupuncture
- •Patients unable to cooperate with acupuncture treatments
- •Pacemaker implantation
- •Previous history of epilepsy
- •Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks
- •Patients who have participated in other trials within 3 months
研究组 & 干预措施
High-dose acupuncture with intravenous infusion of ramosetron
Three sessions of acupuncture on the points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4), Pericardium 6 (PC6), Heart 8 (HT8), and Gall Bladder 41 (GB41) within 48 hours after surgery
干预措施: High-dose acupuncture with intravenous infusion of ramosetron (Procedure)
High-dose acupuncture with intravenous infusion of ramosetron
Three sessions of acupuncture on the points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4), Pericardium 6 (PC6), Heart 8 (HT8), and Gall Bladder 41 (GB41) within 48 hours after surgery
干预措施: P6 stimulation with intravenous infusion of ramosetron (Device)
High-dose acupuncture with intravenous infusion of ramosetron
Three sessions of acupuncture on the points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4), Pericardium 6 (PC6), Heart 8 (HT8), and Gall Bladder 41 (GB41) within 48 hours after surgery
干预措施: Intravenous infusion of ramosetron (Drug)
P6 stimulation with intravenous infusion of ramosetron
P6 stimulation by wearing a study wristband within 48 hours after surgery
干预措施: P6 stimulation with intravenous infusion of ramosetron (Device)
P6 stimulation with intravenous infusion of ramosetron
P6 stimulation by wearing a study wristband within 48 hours after surgery
干预措施: Intravenous infusion of ramosetron (Drug)
Intravenous infusion of ramosetron
A mixture of standard antiemetic medication (5-Hydroxytryptophan receptor antagonist; ramosetron hydrochloride 0.3 mg) and analgesics, including anon-steroidal anti-inflammatory drug (NSAID) (ketorolac tromethamine 120 mg), and a semi-synthesized opioid (oxycodone 20 mg), will be infused by intravenous patient-controlled analgesia (1ml bolus/20 min lockout, 1ml/hr continuous infusion).
干预措施: Intravenous infusion of ramosetron (Drug)
结局指标
主要结局
Number of patients who experience moderate or severe level nausea or vomiting
时间窗: at 24 hours after surgery
Number of patients who experience moderate or severe level nausea (i.e, at least 4 points of nausea on 0 to 10 numeric rating scale) or vomiting during the first 24 postoperative hours
次要结局
- Use of medication(at 2 weeks after surgery)
- Cumulative number of patients who experience nausea(at baseline to 24 and 48 hours)
- Number of vomiting(from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery))
- Cumulative incidence of vomiting(at baseline to 24 and 48 hours)
- Number of patients who experience nausea(from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery))
- Nausea scores on a numeric rating scale(at baseline (the discharge of recovery room), 6, 12, 24, 48 hours from baseline and at discharge (until discharge, an expected average of 7 days after surgery))
- Pain scores on a numeric rating scale(at 6, 12, 24, 48 hours from the discharge of recovery room and at discharge (until discharge, an expected average of 7 days after surgery))
- Time to first defecation(until discharge, an expected average of 7 days after surgery)
- Number of patients who experience vomiting(from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery))
- Cumulative number of patients who experience vomiting(at baseline to 24 and 48 hours)
- Patient's global assessment of recovery after surgery(at 2 weeks after surgery)
- Time to tolerate soft diet(until discharge, an expected average of 7 days after surgery)
- Number of insertions of nasogastric tube(until discharge, an expected average of 7 days after surgery)
- Patient-reported satisfaction for management of PONV(at 48 hours after surgery)
- Time to first flatus(until discharge, an expected average of 7 days after surgery)
- Time to independent walk(until discharge, an expected average of 7 days after surgery)
- Number of reinsertions of Foley catheter(until discharge, an expected average of 7 days after surgery)
- Number of clean intermittent catheterizations(until discharge, an expected average of 7 days after surgery)
- Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30(at 2 weeks after surgery)
- Preoperative anxiety(just before the induction of anaesthesia)
- Postoperative complications(within 4 weeks after surgery)
- Time to first removal of Foley catheter(until discharge, an expected average of 7 days after surgery)
- Serious adverse events(within 4 weeks after surgery)
研究者
Kim Hee Young
Assistant Professor
Pusan National University Yangsan Hospital