Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery

NCT02509143 | Completed

• 1 other identifier: 03-2015-010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting; Colorectal Neoplasms

Keywords

Postoperative Nausea and Vomiting; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (23)

• 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)

• 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)

• Cumulative number of patients who experience nausea

  at baseline to 24 and 48 hours

Study Arms (3)

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

Procedure: High-dose acupuncture with intravenous infusion of ramosetron; Device: P6 stimulation with intravenous infusion of ramosetron; Drug: Intravenous infusion of ramosetron

P6 stimulation with intravenous infusion of ramosetron

ACTIVE COMPARATOR

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

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).

Drug: Intravenous infusion of ramosetron

Interventions

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.

Also known as: Acupuncture

High-dose acupuncture with intravenous infusion of ramosetron

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.

Also known as: PC6

High-dose acupuncture with intravenous infusion of ramosetron; P6 stimulation with intravenous infusion of ramosetron

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.

Also known as: Antiemetics

High-dose acupuncture with intravenous infusion of ramosetron; Intravenous infusion of ramosetron; P6 stimulation with intravenous infusion of ramosetron

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead
• Korea Institute of Oriental Medicine: collaborator
• Korean Medicine Hospital of Pusan National University: collaborator

Study Sites (2)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Yangsan, Kyung Sang South Province, 626-770, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Kyung Sang South Province, 626-770, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28052910 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Colorectal Neoplasms

Interventions

Acupuncture Therapy; Antiemetics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Study Officials

• Hee Young Kim, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 27, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

KR (2)