Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery (AcuPONV)

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Postoperative Nausea and Vomiting; Colorectal Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02509143

03-2015-010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

High-dose acupuncture with intravenous infusion of ramosetron

Experimental group

Description:

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

Treatment:

Device: P6 stimulation with intravenous infusion of ramosetron

Procedure: High-dose acupuncture with intravenous infusion of ramosetron

Drug: Intravenous infusion of ramosetron

P6 stimulation with intravenous infusion of ramosetron

Active Comparator group

Description:

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

Treatment:

Device: P6 stimulation with intravenous infusion of ramosetron

Drug: Intravenous infusion of ramosetron

Intravenous infusion of ramosetron

Active Comparator group

Description:

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).

Treatment:

Drug: Intravenous infusion of ramosetron