Postoperative Nausea and VomitingAcuPONVNCT02509143
Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery
A study testing High-dose acupuncture with intravenous infusion of ramosetron, P6 stimulation with intravenous infusion of ramosetron and Intravenous infusion of ramosetron in people with Postoperative Nausea and Vomiting and Colorectal Neoplasms, run by Pusan National University Yangsan Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Colorectal Neoplasms
- What is being tested?
- High-dose acupuncture with intravenous infusion of ramosetron, P6 stimulation with intravenous infusion of ramosetron and Intravenous infusion of ramosetron
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jul 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
Yangsan, Kyung Sang South Province, 626-770
Pusan National University Yangsan Hospital
Yangsan, Kyung Sang South Province, 626-770
About this study
Official title: High-dose Acupuncture for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Surgery: A Randomized Controlled Pilot Study
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.
Read the 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.
- Being tested
- High-dose acupuncture with intravenous infusion of ramosetron, P6 stimulation with intravenous infusion of ramosetron, Intravenous infusion of ramosetron
- Keywords
- Postoperative Nausea and Vomiting, Colorectal Neoplasms
- Medical subject headings
- Postoperative Nausea and Vomiting, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose acupuncture with intravenous infusion of ramosetronProcedure or surgery
Also called Acupuncture
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.
P6 stimulation with intravenous infusion of ramosetronDevice
Also called PC6
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 ramosetronDrug
Also called Antiemetics
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.
| Study group | Role | What they receive |
|---|---|---|
| High-dose acupuncture with intravenous infusion of ramosetron | Experimental | 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 Receives: Procedure: High-dose acupuncture with intravenous infusion of ramosetron; Device: P6 stimulation with intravenous infusion of ramosetron; Drug: Intravenous infusion of ramosetron |
| P6 stimulation with intravenous infusion of ramosetron | Active comparator | P6 stimulation by wearing a study wristband within 48 hours after surgery Receives: Device: P6 stimulation with intravenous infusion of ramosetron; Drug: Intravenous infusion of ramosetron |
| Intravenous infusion of ramosetron | Active comparator | 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). Receives: Drug: Intravenous infusion of ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 24 hours after surgery
Secondary outcomes (23)
Nausea scores on a numeric rating scale
Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)
Measured: 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)
Number of vomiting
Number of vomiting
Measured: 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)
Cumulative incidence of vomiting
Cumulative incidence of vomiting
Measured: at baseline to 24 and 48 hours
Number of patients who experience nausea
Number of patients who experience nausea
Measured: 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)
Cumulative number of patients who experience nausea
Cumulative number of patients who experience nausea
Measured: at baseline to 24 and 48 hours
Number of patients who experience vomiting
Number of patients who experience vomiting
Measured: 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)
Cumulative number of patients who experience vomiting
Cumulative number of patients who experience vomiting
Measured: at baseline to 24 and 48 hours
Pain scores on a numeric rating scale
Score ranges from 0 (no nausea at all) to 10 (the worst nausea imaginable)
Measured: 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)
Patient's global assessment of recovery after surgery
Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.
Measured: at 2 weeks after surgery
Time to first flatus
Time to first flatus
Measured: until discharge, an expected average of 7 days after surgery
Time to tolerate soft diet
Time to tolerate soft diet
Measured: until discharge, an expected average of 7 days after surgery
Time to first defecation
Time to first defecation
Measured: until discharge, an expected average of 7 days after surgery
Time to independent walk
Time to independent walk
Measured: until discharge, an expected average of 7 days after surgery
Number of insertions of nasogastric tube
Number of insertions of nasogastric tube
Measured: until discharge, an expected average of 7 days after surgery
Time to first removal of Foley catheter
Time to first removal of Foley catheter
Measured: until discharge, an expected average of 7 days after surgery
Number of reinsertions of Foley catheter
Number of reinsertions of Foley catheter
Measured: until discharge, an expected average of 7 days after surgery
Number of clean intermittent catheterizations
Number of clean intermittent catheterizations
Measured: until discharge, an expected average of 7 days after surgery
Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30
Quality of life measured by European Organization for Research and Treatment
Measured: at 2 weeks after surgery
Preoperative anxiety
measured by 0 to 10 numeric rating scale (0: no anxiety, 10: extreme anxiety)
Measured: just before the induction of anaesthesia
Patient-reported satisfaction for management of PONV
measured by 0 to 10 numeric rating scale (0: very unsatisfactory, 10: very satisfactory)
Measured: at 48 hours after surgery
Use of medication
Use of medication
Measured: at 2 weeks after surgery
Postoperative complications
- wound infection
- urinary tract infection
- urinary retention
- chest infection
- other infection
- paralytic ileus
Measured: within 4 weeks after surgery
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
Measured: within 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine, Korean Medicine Hospital of Pusan National University
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509143
- Sponsor's protocol ID
- 03-2015-010
- Acronym
- AcuPONV
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2015
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KH, Kim DH, Bae JM, Son GM, Kim KH, Hong SP, Yang GY, Kim HY. Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial. BMJ Open. 2017 Jan 4;7(1):e013457. doi: 10.1136/bmjopen-2016-013457.
PubMed 28052910
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Acupuncture for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Surgery: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02509143
- Acronym / sponsor ID
- AcuPONV / 03-2015-010
- Keywords
- Postoperative Nausea and Vomiting, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine, Korean Medicine Hospital of Pusan National University
- Study start
- Jul 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose acupuncture with intravenous infusion of ramosetron | Experimental | Procedure: High-dose acupuncture with intravenous infusion of ramosetron, Device: P6 stimulation with intravenous infusion of ramosetron, Drug: Intravenous infusion of ramosetronThree 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 | Active comparator | Device: P6 stimulation with intravenous infusion of ramosetron, Drug: Intravenous infusion of ramosetronP6 stimulation by wearing a study wristband within 48 hours after surgery |
| Intravenous infusion of ramosetron | Active comparator | Drug: Intravenous infusion of ramosetronA 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose acupuncture with intravenous infusion of ramosetronAlso: AcupunctureThree 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. | Procedure or surgery | High-dose acupuncture with intravenous infusion of ramosetron |
| P6 stimulation with intravenous infusion of ramosetronAlso: PC6Stimulation 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. | Device | High-dose acupuncture with intravenous infusion of ramosetron, P6 stimulation with intravenous infusion of ramosetron |
| Intravenous infusion of ramosetronAlso: AntiemeticsIntravenous 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. | Drug | High-dose acupuncture with intravenous infusion of ramosetron, Intravenous infusion of ramosetron, P6 stimulation with intravenous infusion of ramosetron |
Primary outcome
Number of patients who experience moderate or severe level nausea or vomiting
Time frame: 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
23 secondary outcomes
Nausea scores on a numeric rating scale
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)
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)
Cumulative incidence of vomiting
Time frame: at baseline to 24 and 48 hours
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)
Cumulative number of patients who experience nausea
Time frame: at baseline to 24 and 48 hours
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)
Cumulative number of patients who experience vomiting
Time frame: at baseline to 24 and 48 hours
Pain scores on a numeric rating scale
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)
Patient's global assessment of recovery after surgery
Time frame: at 2 weeks after surgery
Time to first flatus
Time frame: until discharge, an expected average of 7 days after surgery
Time to tolerate soft diet
Time frame: until discharge, an expected average of 7 days after surgery
Time to first defecation
Time frame: until discharge, an expected average of 7 days after surgery
Time to independent walk
Time frame: until discharge, an expected average of 7 days after surgery
Number of insertions of nasogastric tube
Time frame: until discharge, an expected average of 7 days after surgery
Time to first removal of Foley catheter
Time frame: until discharge, an expected average of 7 days after surgery
Number of reinsertions of Foley catheter
Time frame: until discharge, an expected average of 7 days after surgery
Number of clean intermittent catheterizations
Time frame: until discharge, an expected average of 7 days after surgery
Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30
Time frame: at 2 weeks after surgery
Preoperative anxiety
Time frame: just before the induction of anaesthesia
Patient-reported satisfaction for management of PONV
Time frame: at 48 hours after surgery
Use of medication
Time frame: at 2 weeks after surgery
Postoperative complications
Time frame: within 4 weeks after surgery
Serious adverse events
Time frame: within 4 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 28052910Kim KH, Kim DH, Bae JM, Son GM, Kim KH, Hong SP, Yang GY, Kim HY. Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial. BMJ Open. 2017 Jan 4;7(1):e013457. doi: 10.1136/bmjopen-2016-013457.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Young Kim, PhD principal investigator
Pusan National University Yangsan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose acupuncture with intravenous infusion of ramosetron, P6 stimulation with intravenous infusion of ramosetron and Intravenous infusion of ramosetron in people with Postoperative Nausea and Vomiting and Colorectal Neoplasms, run by Pusan National University Yangsan Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experience moderate or severe level nausea or vomiting (time frame: at 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02509143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.