PONVPONVNCT04866121
Acupuncture for Prevention of Postoperative Nausea and Vomiting
A study testing Acupuncture in people with PONV, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the single point stimulation (P6) and double point stimulation (P6+ST36) performed before anesthesia induction with standard treatment in terms of PONV development and postoperative anti-emetic requirement in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- PONV
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 May 2022
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between 18-65 years old, who have ASA scores of I-II-III and who are planned to undergo elective laparoscopic cholecystectomy.
Who cannot join
- Pregnant women
- Lactating women
- Women with steel hypersensitivity
- Mental retarded patients
- Patients with psychological disorders and neurologic sequel
- Additionally, patients who;
Show all 11Show fewer
- have nausea/vomiting, consume anti-emetic or emetogenic drugs, alcohol, opioid drugs, glucocorticoid drug and have acupuncture treatment for any reason 72 hours prior to surgery
- have skin reactions at the site of acupuncture application
- had intraoperative gangrenous cholecystitis, gall bladder perforation, malignant pathological outcome
- were admitted to intensive care unite
- had to convert to open surgery will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Niğde Ömer Halisdemir University Training and Research Hospital
Niğde
Alirıza Erdoğan, MD, 05333558377, alirizaerdogan@ohu.edu.tr
About this study
Official title: The Comparison of P6+ST36 Combination Acupuncture Therapy With P6 Alone Acupuncture and Standard Treatment in Postoperative Nausea and Vomiting
The aim of this study is to compare the single point stimulation (P6) and double point stimulation (P6+ST36) performed before anesthesia induction with standard treatment in terms of PONV development and postoperative anti-emetic requirement in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Postoperative nausea and vomiting (PONV) is encountered in 20-30% of patients undergoing surgery. PONV is a costly medical condition in financial and emotional aspects by causing serious complications like elongation of hospital stay, postoperative bleeding, aspiration pneumonia and electrolyte imbalances. In high risk individuals and operations, it can be encountered in up to 80% of patients. The risk factors for PONV development in adults are female gender, previous PONV and/or motion sickness, non-smoking and younger age. Additionally, it has been reported that some surgery types, especially, laparoscopic cholecystectomy and gynecologic surgeries along with the anesthetic agent, the duration of anesthesia and postoperative opioid use also have direct effects on PONV development.
According to the 4th consensus guidelines for the management of PONV updated in 2020, in patients with one or more risk factors, a multimodal prophylaxis using a combination of at least 2 of the following methods; 5-HT3 receptor antagonists, corticosteroids, anti-histaminics, dopamine antagonists, propofol anesthesia, NK-1 receptor antagonists, anti-cholinergics and acupuncture.
Following the declaration of acupuncture as an effective treatment option for PONV in 1999 NIH Consensus Conference, studies about this topic gained speed and many high quality randomized controlled clinic studies were performed. In one of the most comprehensive reviews published in 2015, it is stated that stimulation of P6 acupuncture point remarkably reduce the risk of PONV development, significantly decrease the amount of postoperative anti-emetic requirement, provide similar PONV prophylaxis with different pharmacoprophylactic agents (metoclopramide, cyclizine, prochlorperazine, droperidol, ondansetron and dexamethasone) and have similar post-operative anti-emetic requirement with pharmacologic agents. In the same Cochrane analysis, it is clearly stated that studies enrolling groups of sham acupuncture for P6 are redundant and would not go any further than duplicating the available well-established information. In this aspect, the proposed study design is comparison between treatment groups.
PONV has a multifactorial ethology. It has been postulated that it occurs as a result of activation of emetic center in the brain stem by stimulation of various peripheral receptors as well as central receptors including the chemoreceptor trigger zone in the postrema region. Following activation, the response of emetic center for anti-emetic agents is rather weak and consequently this complicates PONV treatment. Acupuncture is a kind of periphery sensory stimulus and has modulatory effects on the emetic center in the brain stem via neuronal pathways. This neural modulation is thought to be the result of communication between cerebellum and insula. As a result of these mechanisms of action, performing acupuncture before the induction of anesthesia provides more effective PONV prophylaxis.
Pharmacologic anti-emetic agents increase treatment costs as well as bear some adverse effects. The clinical condition created by PONV and increasing dissatisfaction due to the adverse effects of the pharmacologic agents urge both patients and clinicians pursuing non-pharmacologic modalities with proven efficiency, like acupuncture.
Therefore, it is essential to develop a standard, simple, effective prophylaxis protocol with high patient compliance and without ad verse effects, especially in patients with high risk for PONV. In the literature various different technique and materials were used for acupuncture stimulation. Unfortunately, a standard is not present for the metal of the needle, the length of the needle, the depth of immersion, the technique of stimulation and in most of the studies these features are not specified at all. Meanwhile, although P6 is the most studied point for PONV, there are encouraging evidence that some other points, like ST36 or LI4, might be incorporated into the PONV protocol. ST36 have potential effects in balancing gastrointestinal motility by modulating gastric motility via vagovagal and sympathetic reflex arches. Moreover, P6 in combination with ST36 has been successful in treatment of hiccups, recently.
- Conditions
- PONV
- Being tested
- Acupuncture
- Keywords
- PONV, P6 Acupuncture, ST36 Acupuncture
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
A standardized acupuncture protocol will be administered
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia. |
| Single point (P6) Acupuncture | Active comparator | Prior to the anesthesia induction, the same certified medical doctor will perform a standard acupuncture protocol to the P6 point bilaterally. For P6 acupuncture stimulation 0,25x25mm steel needles will be immersed for 2cm. For stimulation, the needles will be turned clock-wise 3 times. This stimulation will be repeated for 3 times with 10 seconds intervals. The needles will be held in place for 20 minutes and will be removed afterwards.
Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia. Receives: Procedure: Acupuncture |
| Double point (P6+ST36) Acupuncture | Experimental | Prior to the anesthesia induction, the same certified medical doctor will perform a standard acupuncture protocol both to the P6 and ST36 points bilaterally. For P6 acupuncture stimulation 0,25x25mm steel needles will be immersed for 2cm. For ST6 acupuncture stimulation 0,25x50mm steel needles will be immersed for 5cm. For stimulation, the needles will be turned clock-wise 3 times. This stimulation will be repeated for 3 times with 10 seconds intervals. The needles will be held in place for 20 minutes and will be removed afterwards. Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV prophylaxis
The frequency of PONV development
Measured: 12 months
Postoperative anti-emetic requirement
The amount of anti-emetic agent administered postoperatively
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PONVStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alirıza Erdoğan, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866121
- Sponsor's protocol ID
- 14.04.2021/28
- Acronym
- PONV
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
PubMed 32467512Unsal N, Akcaboy ZN, Soyal OB, Akcaboy EY, Mutlu NM, Gogus N. Effectiveness of Intraoperative Laser Acupuncture Combined with Antiemetic Drugs for Prevention of Postoperative Nausea and Vomiting. J Altern Complement Med. 2020 Jan;26(1):67-71. doi: 10.1089/acm.2019.0181. Epub 2019 Oct 3.
PubMed 31580707Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
PubMed 23035051Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
PubMed 26522652Usichenko TI, Hesse T. Appropriate timing and intensity of PC6 stimulation for the prevention of postoperative nausea and vomiting. Acupunct Med. 2016 Feb;34(1):70-1. doi: 10.1136/acupmed-2015-010926. Epub 2015 Aug 18. No abstract available.
PubMed 26286527Bai L, Niu X, Liu Z, Chen Z, Wang X, Sun C, Wang Z, Wang S, Cao J, Gan S, Fan G, Huang W, Xu H, Chen S, Tian J, Lao L, Zhang M. The role of insula-cerebellum connection underlying aversive regulation with acupuncture. Mol Pain. 2018 Jan-Dec;14:1744806918783457. doi: 10.1177/1744806918783457. Epub 2018 Jun 19.
PubMed 29921161Lu MJ, Yu Z, He Y, Yin Y, Xu B. Electroacupuncture at ST36 modulates gastric motility via vagovagal and sympathetic reflexes in rats. World J Gastroenterol. 2019 May 21;25(19):2315-2326. doi: 10.3748/wjg.v25.i19.2315.
PubMed 31148903Sun ZG, Pi YL, Zhang J, Wang M, Zou J, Wu W. Effect of acupuncture at ST36 on motor cortical excitation and inhibition. Brain Behav. 2019 Sep;9(9):e01370. doi: 10.1002/brb3.1370. Epub 2019 Jul 30.
PubMed 31359627Xu J, Qu Y, Yue Y, Zhao H, Gao Y, Peng L, Zhang Q. Treatment of persistent hiccups after arthroplasty: effects of acupuncture at PC6, CV12 and ST36. Acupunct Med. 2019 Feb;37(1):72-76. doi: 10.1136/acupmed-2016-011304. Epub 2019 Mar 7.
PubMed 30843420
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of P6+ST36 Combination Acupuncture Therapy With P6 Alone Acupuncture and Standard Treatment in Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT04866121
- Acronym / sponsor ID
- PONV / 14.04.2021/28
- Conditions
- PONV
- Keywords
- PONV, P6 Acupuncture, ST36 Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 29 Apr 2021 (actual)
- 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.
The aim of this study is to compare the single point stimulation (P6) and double point stimulation (P6+ST36) performed before anesthesia induction with standard treatment in terms of PONV development and postoperative anti-emetic requirement in patients undergoing laparoscopic cholecystectomy.
Detailed description
Postoperative nausea and vomiting (PONV) is encountered in 20-30% of patients undergoing surgery. PONV is a costly medical condition in financial and emotional aspects by causing serious complications like elongation of hospital stay, postoperative bleeding, aspiration pneumonia and electrolyte imbalances. In high risk individuals and operations, it can be encountered in up to 80% of patients. The risk factors for PONV development in adults are female gender, previous PONV and/or motion sickness, non-smoking and younger age. Additionally, it has been reported that some surgery types, especially, laparoscopic cholecystectomy and gynecologic surgeries along with the anesthetic agent, the duration of anesthesia and postoperative opioid use also have direct effects on PONV development.
According to the 4th consensus guidelines for the management of PONV updated in 2020, in patients with one or more risk factors, a multimodal prophylaxis using a combination of at least 2 of the following methods; 5-HT3 receptor antagonists, corticosteroids, anti-histaminics, dopamine antagonists, propofol anesthesia, NK-1 receptor antagonists, anti-cholinergics and acupuncture.
Following the declaration of acupuncture as an effective treatment option for PONV in 1999 NIH Consensus Conference, studies about this topic gained speed and many high quality randomized controlled clinic studies were performed. In one of the most comprehensive reviews published in 2015, it is stated that stimulation of P6 acupuncture point remarkably reduce the risk of PONV development, significantly decrease the amount of postoperative anti-emetic requirement, provide similar PONV prophylaxis with different pharmacoprophylactic agents (metoclopramide, cyclizine, prochlorperazine, droperidol, ondansetron and dexamethasone) and have similar post-operative anti-emetic requirement with pharmacologic agents. In the same Cochrane analysis, it is clearly stated that studies enrolling groups of sham acupuncture for P6 are redundant and would not go any further than duplicating the available well-established information. In this aspect, the proposed study design is comparison between treatment groups.
PONV has a multifactorial ethology. It has been postulated that it occurs as a result of activation of emetic center in the brain stem by stimulation of various peripheral receptors as well as central receptors including the chemoreceptor trigger zone in the postrema region. Following activation, the response of emetic center for anti-emetic agents is rather weak and consequently this complicates PONV treatment. Acupuncture is a kind of periphery sensory stimulus and has modulatory effects on the emetic center in the brain stem via neuronal pathways. This neural modulation is thought to be the result of communication between cerebellum and insula. As a result of these mechanisms of action, performing acupuncture before the induction of anesthesia provides more effective PONV prophylaxis.
Pharmacologic anti-emetic agents increase treatment costs as well as bear some adverse effects. The clinical condition created by PONV and increasing dissatisfaction due to the adverse effects of the pharmacologic agents urge both patients and clinicians pursuing non-pharmacologic modalities with proven efficiency, like acupuncture.
Therefore, it is essential to develop a standard, simple, effective prophylaxis protocol with high patient compliance and without ad verse effects, especially in patients with high risk for PONV. In the literature various different technique and materials were used for acupuncture stimulation. Unfortunately, a standard is not present for the metal of the needle, the length of the needle, the depth of immersion, the technique of stimulation and in most of the studies these features are not specified at all. Meanwhile, although P6 is the most studied point for PONV, there are encouraging evidence that some other points, like ST36 or LI4, might be incorporated into the PONV protocol. ST36 have potential effects in balancing gastrointestinal motility by modulating gastric motility via vagovagal and sympathetic reflex arches. Moreover, P6 in combination with ST36 has been successful in treatment of hiccups, recently.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia. |
| Single point (P6) Acupuncture | Active comparator | Procedure: AcupuncturePrior to the anesthesia induction, the same certified medical doctor will perform a standard acupuncture protocol to the P6 point bilaterally. For P6 acupuncture stimulation 0,25x25mm steel needles will be immersed for 2cm. For stimulation, the needles will be turned clock-wise 3 times. This stimulation will be repeated for 3 times with 10 seconds intervals. The needles will be held in place for 20 minutes and will be removed afterwards. Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia. |
| Double point (P6+ST36) Acupuncture | Experimental | Procedure: AcupuncturePrior to the anesthesia induction, the same certified medical doctor will perform a standard acupuncture protocol both to the P6 and ST36 points bilaterally. For P6 acupuncture stimulation 0,25x25mm steel needles will be immersed for 2cm. For ST6 acupuncture stimulation 0,25x50mm steel needles will be immersed for 5cm. For stimulation, the needles will be turned clock-wise 3 times. This stimulation will be repeated for 3 times with 10 seconds intervals. The needles will be held in place for 20 minutes and will be removed afterwards. Following 8 hours fasting, standard anesthesia protocol, 3 mg kg-1 Propofol, 0.6 mg kg-1 rocuronium and 2 µg kg-1 fentanyl will be administered. Laparoscopic cholecystectomy will be performed. Twenty minutes prior to the completion of the operation tramadol 100mg will be administered for analgesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women between 18-65 years old, who have ASA scores of I-II-III and who are planned to undergo elective laparoscopic cholecystectomy.
Key exclusion criteria (11 listed)
- Pregnant women
- Lactating women
- Women with steel hypersensitivity
- Mental retarded patients
- Patients with psychological disorders and neurologic sequel
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 |
|---|---|---|
| AcupunctureA standardized acupuncture protocol will be administered | Procedure or surgery | Double point (P6+ST36) Acupuncture, Single point (P6) Acupuncture |
Primary outcome
PONV prophylaxis
Time frame: 12 months
The frequency of PONV development
Postoperative anti-emetic requirement
Time frame: 12 months
The amount of anti-emetic agent administered postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 32467512Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
- Background: PubMed 31580707Unsal N, Akcaboy ZN, Soyal OB, Akcaboy EY, Mutlu NM, Gogus N. Effectiveness of Intraoperative Laser Acupuncture Combined with Antiemetic Drugs for Prevention of Postoperative Nausea and Vomiting. J Altern Complement Med. 2020 Jan;26(1):67-71. doi: 10.1089/acm.2019.0181. Epub 2019 Oct 3.
- Background: PubMed 23035051Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
- Background: PubMed 26522652Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
- Background: PubMed 26286527Usichenko TI, Hesse T. Appropriate timing and intensity of PC6 stimulation for the prevention of postoperative nausea and vomiting. Acupunct Med. 2016 Feb;34(1):70-1. doi: 10.1136/acupmed-2015-010926. Epub 2015 Aug 18. No abstract available.
- Background: PubMed 29921161Bai L, Niu X, Liu Z, Chen Z, Wang X, Sun C, Wang Z, Wang S, Cao J, Gan S, Fan G, Huang W, Xu H, Chen S, Tian J, Lao L, Zhang M. The role of insula-cerebellum connection underlying aversive regulation with acupuncture. Mol Pain. 2018 Jan-Dec;14:1744806918783457. doi: 10.1177/1744806918783457. Epub 2018 Jun 19.
- Background: PubMed 31148903Lu MJ, Yu Z, He Y, Yin Y, Xu B. Electroacupuncture at ST36 modulates gastric motility via vagovagal and sympathetic reflexes in rats. World J Gastroenterol. 2019 May 21;25(19):2315-2326. doi: 10.3748/wjg.v25.i19.2315.
- Background: PubMed 31359627Sun ZG, Pi YL, Zhang J, Wang M, Zou J, Wu W. Effect of acupuncture at ST36 on motor cortical excitation and inhibition. Brain Behav. 2019 Sep;9(9):e01370. doi: 10.1002/brb3.1370. Epub 2019 Jul 30.
- Background: PubMed 30843420Xu J, Qu Y, Yue Y, Zhao H, Gao Y, Peng L, Zhang Q. Treatment of persistent hiccups after arthroplasty: effects of acupuncture at PC6, CV12 and ST36. Acupunct Med. 2019 Feb;37(1):72-76. doi: 10.1136/acupmed-2016-011304. Epub 2019 Mar 7.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with PONV, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alirıza Erdoğan, MD (05333558377, alirizaerdogan@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV prophylaxis (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04866121, which also lists 9 linked publications.
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 3 May 2021.