Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting; Colorectal Neoplasms
• Interventions: Procedure: High-dose acupuncture with intravenous infusion of ramosetron; Device: P6 stimulation with intravenous infusion of ramosetron; Drug: Intravenous infusion of ramosetron

• Registration Number: NCT02509143
• Lead Sponsor: Pusan National University Yangsan Hospital

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-27
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose acupuncture with intravenous infusion of ramosetron	P6 stimulation with intravenous infusion of ramosetron	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
High-dose acupuncture with intravenous infusion of ramosetron	High-dose acupuncture with intravenous infusion of ramosetron	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
High-dose acupuncture with intravenous infusion of ramosetron	Intravenous infusion of ramosetron	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 with intravenous infusion of ramosetron	P6 stimulation with intravenous infusion of ramosetron	P6 stimulation by wearing a study wristband within 48 hours after surgery
P6 stimulation with intravenous infusion of ramosetron	Intravenous infusion of ramosetron	P6 stimulation by wearing a study wristband within 48 hours after surgery
Intravenous infusion of ramosetron	Intravenous infusion of ramosetron	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Use of medication	at 2 weeks after surgery	Use of medication
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
Cumulative number of patients who experience nausea	at baseline to 24 and 48 hours	Cumulative number of patients who experience nausea
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)
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)
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
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 tolerate soft diet	until discharge, an expected average of 7 days after surgery	Time to tolerate soft diet
Number of insertions of nasogastric tube	until discharge, an expected average of 7 days after surgery	Number of insertions of nasogastric tube
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)
Time to first flatus	until discharge, an expected average of 7 days after surgery	Time to first flatus
Time to first defecation	until discharge, an expected average of 7 days after surgery	Time to first defecation
Time to independent walk	until discharge, an expected average of 7 days after surgery	Time to independent walk
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)
Postoperative complications	within 4 weeks after surgery	* wound infection; * urinary tract infection; * urinary retention; * chest infection; * other infection; * paralytic ileus
Time to first removal of Foley catheter	until discharge, an expected average of 7 days after surgery	Time to first removal of Foley catheter
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

Trial Locations

Locations (2)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University; 🇰🇷 Yangsan, Kyung Sang South Province, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Kyung Sang South Province, Korea, Republic of