Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

November 30, 2016

Study Completion Date

December 31, 2016

Conditions
Postoperative Nausea and VomitingColorectal Neoplasms
Interventions
PROCEDURE

High-dose acupuncture with intravenous infusion of ramosetron

"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."

DEVICE

P6 stimulation 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.

DRUG

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."

Trial Locations (2)

626-770

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

Pusan National University Yangsan Hospital, Yangsan

All Listed Sponsors
collaborator

Korea Institute of Oriental Medicine

OTHER_GOV

collaborator

Korean Medicine Hospital of Pusan National University

OTHER

lead

Pusan National University Yangsan Hospital

OTHER

NCT02509143 - Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery | Biotech Hunter | Biotech Hunter