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

Primary Purpose

Postoperative Nausea and Vomiting, Colorectal Neoplasms

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

High-dose acupuncture with intravenous infusion of ramosetron

P6 stimulation with intravenous infusion of ramosetron

Intravenous infusion of ramosetron

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Colorectal Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

High-dose acupuncture with intravenous infusion of ramosetron

P6 stimulation with intravenous infusion of ramosetron

Intravenous infusion of ramosetron

Arm 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

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nausea scores on a numeric rating scale

Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)

Number of vomiting

Cumulative incidence of vomiting

Number of patients who experience nausea

Cumulative number of patients who experience nausea

Number of patients who experience vomiting

Pain scores on a numeric rating scale

Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)

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 to first flatus

Time to tolerate soft diet

Time to first defecation

Time to independent walk

Number of insertions of nasogastric tube

Time to first removal of Foley catheter

Number of reinsertions of Foley catheter

Number of clean intermittent catheterizations

Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30

Preoperative anxiety

measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety)

Patient-reported satisfaction for management of PONV

measured by 0 to 10 numeric rating scale (0: very unsatisfactory, 10: very satisfactory)

Use of medication

Postoperative complications

wound infection urinary tract infection urinary retention chest infection other infection paralytic ileus

Serious adverse events

respiratory failure requiring ventilation renal failure requiring dialysis cardiac failure myocardial infarction anastomotic leakage requiring surgery anastomotic leakage requiring drainage bowel obstruction/stricture requiring surgery abdominal wall dehiscence requiring surgery readmission within 30 days after surgery reoperation within 30 days after surgery mortality during surgery or within 30 days after surgery

Full Information

NCT ID

NCT02509143

First Posted

July 17, 2015

Last Updated

March 7, 2017

Sponsor

Pusan National University Yangsan Hospital

Collaborators

Korea Institute of Oriental Medicine, Korean Medicine Hospital of Pusan National University

1. Study Identification

Unique Protocol Identification Number

NCT02509143

Brief Title

Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery

Acronym

AcuPONV

Official Title

High-dose Acupuncture for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Surgery: A Randomized Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pusan National University Yangsan Hospital

Collaborators

Korea Institute of Oriental Medicine, Korean Medicine Hospital of Pusan National University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting, Colorectal Neoplasms

Keywords

Postoperative Nausea and Vomiting, Colorectal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-dose acupuncture with intravenous infusion of ramosetron

Arm Type

Experimental

Arm Description

Arm Title

P6 stimulation with intravenous infusion of ramosetron

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intravenous infusion of ramosetron

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

High-dose acupuncture with intravenous infusion of ramosetron

Other Intervention Name(s)

Acupuncture

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

P6 stimulation with intravenous infusion of ramosetron

Other Intervention Name(s)

PC6

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Intravenous infusion of ramosetron

Other Intervention Name(s)

Antiemetics

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of patients who experience moderate or severe level nausea or vomiting

Description

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 Outcome Measure Information:

Title

Nausea scores on a numeric rating scale

Description

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)

Title

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)

Title

Cumulative incidence of vomiting

Time Frame

at baseline to 24 and 48 hours

Title

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)

Title

Cumulative number of patients who experience nausea

Time Frame

at baseline to 24 and 48 hours

Title

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)

Title

Pain scores on a numeric rating scale

Description

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)

Title

Patient's global assessment of recovery after surgery

Description

Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.

Time Frame

at 2 weeks after surgery

Title

Time to first flatus

Time Frame