Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Nausea

Vomiting

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Postoperative Complications

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Anti-Inflammatory Agents

Antirheumatic Agents

Antiemetics

Gastrointestinal Agents

Psychotropic Drugs

Oxycodone

Analgesics, Opioid

Liver Extracts

Ketorolac

Ketorolac Tromethamine

Ramosetron

5-Hydroxytryptophan

Serotonin

Neurotransmitter Agents

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

P6 stimulation by wearing a study wristband within 48 hours after surgery

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).

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.

High-dose acupuncture with intravenous infusion of ramosetron

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.

P6 stimulation with intravenous infusion of ramosetron

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.

Intravenous infusion of ramosetron

Hee Young Kim, PhD

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.

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.

Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery

High-dose Acupuncture for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Surgery: A Randomized Controlled Pilot Study

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

Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)

Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.

measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety)

measured by 0 to 10 numeric rating scale (0: very unsatisfactory, 10: very satisfactory)

* wound infection
* urinary tract infection
* urinary retention
* chest infection
* other infection
* paralytic ileus

* 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery	NCT02509143	Postoperative N... Colorectal Neop...	High-dose acupu... P6 stimulation ... Intravenous inf...	18 Years - 80 Years	Pusan National University Yangsan Hospital
Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery	NCT02509143	Postoperative N... Colorectal Neop...	High-dose acupu... P6 stimulation ... Intravenous inf...	18 Years - 80 Years	Pusan National University Yangsan Hospital

Spots Global Cancer Trial Database for p6 stimulation with intravenous infusion of ramosetron