Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery
Condition: Postoperative Nausea and Vomiting; Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms; Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): High-dose acupuncture with intravenous infusion of ramosetron; P6 stimulation with intravenous infusion of ramosetron; Intravenous infusion of ramosetron
Intervention type(s): Procedure; Device; Drug
Intervention description(s): 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.; 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 (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.
Other intervention name(s): Acupuncture; PC6; Antiemetics
Intervention MeSH terms: Ramosetron; Antiemetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Nausea and Vomiting; Colorectal Neoplasms