Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery

Pusan National University Yangsan Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

High-dose acupuncture with intravenous infusion of ramosetronPROCEDURE

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.

P6 stimulation with intravenous infusion of ramosetronDEVICE

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.

Intravenous infusion of ramosetronDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Time frame: at baseline to 24 and 48 hours

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

Time frame: at baseline to 24 and 48 hours

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

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