Colorectal Neoplasms, Postoperative Nausea and Vomiting
Conditions
Keywords
Postoperative Nausea and Vomiting, Colorectal Neoplasms
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREHigh-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.
DEVICEP6 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.
DRUGIntravenous 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.
Sponsors
Korea Institute of Oriental Medicine
Korean Medicine Hospital of Pusan National University
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who experience moderate or severe level nausea or vomiting | at 24 hours after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Nausea scores on a numeric rating scale | 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) | Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable) |
| Number of vomiting | 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) | Number of vomiting |
| Cumulative incidence of vomiting | at baseline to 24 and 48 hours | Cumulative incidence of vomiting |
| Number of patients who experience nausea | 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) | Number of patients who experience nausea |
| Number of patients who experience vomiting | 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) | Number of patients who experience vomiting |
| Cumulative number of patients who experience vomiting | at baseline to 24 and 48 hours | Cumulative number of patients who experience vomiting |
| Pain scores on a numeric rating scale | 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) | Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable) |
| Patient's global assessment of recovery after surgery | at 2 weeks after surgery | Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened. |
| Time to first flatus | until discharge, an expected average of 7 days after surgery | Time to first flatus |
| Time to tolerate soft diet | until discharge, an expected average of 7 days after surgery | Time to tolerate soft diet |
| Time to first defecation | until discharge, an expected average of 7 days after surgery | Time to first defecation |
| Cumulative number of patients who experience nausea | at baseline to 24 and 48 hours | Cumulative number of patients who experience nausea |
| Number of insertions of nasogastric tube | until discharge, an expected average of 7 days after surgery | Number of insertions of nasogastric tube |
| Time to first removal of Foley catheter | until discharge, an expected average of 7 days after surgery | Time to first removal of Foley catheter |
| Number of reinsertions of Foley catheter | until discharge, an expected average of 7 days after surgery | Number of reinsertions of Foley catheter |
| Number of clean intermittent catheterizations | until discharge, an expected average of 7 days after surgery | 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 | at 2 weeks after surgery | Quality of life measured by European Organization for Research and Treatment |
| Preoperative anxiety | just before the induction of anaesthesia | measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety) |
| Patient-reported satisfaction for management of PONV | at 48 hours after surgery | measured by 0 to 10 numeric rating scale (0: very unsatisfactory, 10: very satisfactory) |
| Use of medication | at 2 weeks after surgery | Use of medication |
| Postoperative complications | within 4 weeks after surgery | * wound infection * urinary tract infection * urinary retention * chest infection * other infection * paralytic ileus |
| Serious adverse events | within 4 weeks after surgery | * 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 |
| Time to independent walk | until discharge, an expected average of 7 days after surgery | Time to independent walk |
Countries
South Korea
Outcome results
None listed