An interventional study of High-dose acupuncture with intravenous infusion of ramosetron and P6 stimulation with intravenous infusion of ramosetron in Postoperative Nausea and Vomiting and Colorectal Neoplasms, sponsored by Pusan National University Yangsan Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 60 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
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
Procedure: High-dose acupuncture with intravenous infusion of ramosetron · Device: P6 stimulation with intravenous infusion of ramosetron · Drug: Intravenous infusion of ramosetron
P6 stimulation by wearing a study wristband within 48 hours after surgery
Device: P6 stimulation with 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).
Drug: Intravenous infusion of ramosetron
Three sessions of acupuncture will be provided within 48 hours after surgery. Electrical stimulation with an alternating frequency of 2 to 100 Hz will be applied to selected points (PC6 to LI4, ST36 to ST37, and bilateral SP6). An embedded acupuncture technique for preoperative anxiety will be applied to the bilateral acupuncture points of Liver (LI4), Heart 7 (HT7), Stomach (ST36), Yin-Tang, ear Shen-Men,and ear sympathetic and will be removed the next day. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience. The same stimulation of P6 points and antiemetics will be provided to the P6 acupuncture-point stimulation group.
Also known as: Acupuncture
Stimulation of P6 points will be maintained from one hour before and for 48 hours after surgery by wearing a wristband that produces pulse-type transcutaneous electrical stimulation. Antiemetics will be provided, the same as the standard antiemetic medication alone group.
Also known as: PC6
Intravenous infusion of (oxycodone 20mg, ketorolac 120mg, ramosetron 0.3mg) as standard antiemetic medication will be provided. A dose of continuous infusion will be reduced by 0.1 ml/hr when a patient complaints of nausea. When vomiting occurs, a dose of continuous infusion will be reduced by 0.2 ml/hr and a bolus infusion of ramosetron 0.3 mg will be provided. A bolus infusion of ramosetron 0.3 mg will be also given if a patient feels greater than or equal to six points of nausea as measured on a 0 to 10 numeric rating scale (NRS) (nausea-severity scale) or by the patient's request, regardless of the severity of the nausea.
Also known as: Antiemetics
Number of patients who experience moderate or severe level nausea or vomiting
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
Time frame: at 24 hours after surgery
Nausea scores on a numeric rating scale
Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)
Time frame: 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)
Number of vomiting
Number of vomiting
Time frame: 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
Cumulative incidence of vomiting
Time frame: at baseline to 24 and 48 hours
Number of patients who experience nausea
Number of patients who experience nausea
Time frame: 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 nausea
Cumulative number of patients who experience nausea
Time frame: at baseline to 24 and 48 hours
Number of patients who experience vomiting
Number of patients who experience vomiting
Time frame: 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
Cumulative number of patients who experience vomiting
Time frame: at baseline to 24 and 48 hours
Pain scores on a numeric rating scale
Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)
Time frame: 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)
Patient's global assessment of recovery after surgery
Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.
Time frame: at 2 weeks after surgery
Time to first flatus
Time to first flatus
Time frame: until discharge, an expected average of 7 days after surgery
Time to tolerate soft diet
Time to tolerate soft diet
Time frame: until discharge, an expected average of 7 days after surgery
Time to first defecation
Time to first defecation
Time frame: until discharge, an expected average of 7 days after surgery
Time to independent walk
Time to independent walk
Time frame: until discharge, an expected average of 7 days after surgery
Number of insertions of nasogastric tube
Number of insertions of nasogastric tube
Time frame: until discharge, an expected average of 7 days after surgery
Time to first removal of Foley catheter
Time to first removal of Foley catheter
Time frame: until discharge, an expected average of 7 days after surgery
Number of reinsertions of Foley catheter
Number of reinsertions of Foley catheter
Time frame: until discharge, an expected average of 7 days after surgery
Number of clean intermittent catheterizations
Number of clean intermittent catheterizations
Time frame: 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
Quality of life measured by European Organization for Research and Treatment
Time frame: at 2 weeks after surgery
Preoperative anxiety
measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety)
Time frame: just before the induction of anaesthesia
Patient-reported satisfaction for management of PONV
measured by 0 to 10 numeric rating scale (0: very unsatisfactory, 10: very satisfactory)
Time frame: at 48 hours after surgery
Use of medication
Use of medication
Time frame: at 2 weeks after surgery
Postoperative complications
* wound infection * urinary tract infection * urinary retention * chest infection * other infection * paralytic ileus
Time frame: within 4 weeks after surgery
Serious adverse events
* respiratory failure requiring ventilation * renal failure requiring dialysis * cardiac failure * myocardial infarction * anastomotic leakage requiring surgery * anastomotic leakage requiring drainage * bowel obstruction/stricture requiring surgery * abdominal wall dehiscence requiring surgery * readmission within 30 days after surgery * reoperation within 30 days after surgery * mortality during surgery or within 30 days after surgery
Time frame: within 4 weeks after surgery
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Pusan National University Yangsan Hospital