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| Name | Class |
|---|---|
| Korea Institute of Oriental Medicine | OTHER_GOV |
| Korean Medicine Hospital of Pusan National University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose acupuncture with intravenous infusion of ramosetron | Experimental | 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 |
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| P6 stimulation with intravenous infusion of ramosetron | Active Comparator | P6 stimulation by wearing a study wristband within 48 hours after surgery |
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| Intravenous infusion of ramosetron | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose acupuncture with intravenous infusion of ramosetron | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea scores on a numeric rating scale | Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Young Kim, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Clinical Research Center, Korean Medicine Hospital, Pusan National University | Yangsan | Kyung Sang South Province | 626-770 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28052910 | Derived | Kim KH, Kim DH, Bae JM, Son GM, Kim KH, Hong SP, Yang GY, Kim HY. Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial. BMJ Open. 2017 Jan 4;7(1):e013457. doi: 10.1136/bmjopen-2016-013457. |
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| P6 stimulation with intravenous infusion of ramosetron | Device | 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. |
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| Intravenous infusion of ramosetron | Drug | 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. |
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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 | Cumulative incidence of vomiting | at baseline to 24 and 48 hours |
| Number of patients who experience nausea | 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) |
| Cumulative number of patients who experience nausea | Cumulative number of patients who experience nausea | at baseline to 24 and 48 hours |
| Number of patients who experience vomiting | 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 | Cumulative number of patients who experience vomiting | 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) | 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. | at 2 weeks after surgery |
| Time to first flatus | Time to first flatus | until discharge, an expected average of 7 days after surgery |
| Time to tolerate soft diet | Time to tolerate soft diet | until discharge, an expected average of 7 days after surgery |
| Time to first defecation | Time to first defecation | until discharge, an expected average of 7 days after surgery |
| Time to independent walk | Time to independent walk | until discharge, an expected average of 7 days after surgery |
| Number of insertions of nasogastric tube | Number of insertions of nasogastric tube | until discharge, an expected average of 7 days after surgery |
| Time to first removal of Foley catheter | Time to first removal of Foley catheter | until discharge, an expected average of 7 days after surgery |
| Number of reinsertions of Foley catheter | Number of reinsertions of Foley catheter | until discharge, an expected average of 7 days after surgery |
| Number of clean intermittent catheterizations | 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 | Quality of life measured by European Organization for Research and Treatment | at 2 weeks after surgery |
| Preoperative anxiety | measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety) | 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) | at 48 hours after surgery |
| Use of medication | Use of medication | at 2 weeks after surgery |
| Postoperative complications |
| within 4 weeks after surgery |
| Serious adverse events |
| within 4 weeks after surgery |
| Pusan National University Yangsan Hospital | Yangsan | Kyung Sang South Province | 626-770 | South Korea |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000932 | Antiemetics |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001337 | Autonomic Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D005765 | Gastrointestinal Agents |
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