- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04866121
Acupuncture for Prevention of Postoperative Nausea and Vomiting (PONV)
The Comparison of P6+ST36 Combination Acupuncture Therapy With P6 Alone Acupuncture and Standard Treatment in Postoperative Nausea and Vomiting
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Alirıza Erdoğan, MD
- Telefonní číslo: 05333558377
- E-mail: alirizaerdogan@ohu.edu.tr
Studijní místa
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Niğde, Krocan
- Nábor
- Niğde Ömer Halisdemir University Training and Research Hospital
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Kontakt:
- Alirıza Erdoğan, MD
- Telefonní číslo: 05333558377
- E-mail: alirizaerdogan@ohu.edu.tr
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Women between 18-65 years old, who have ASA scores of I-II-III and who are planned to undergo elective laparoscopic cholecystectomy.
Exclusion Criteria:
- Pregnant women
- Lactating women
- Women with steel hypersensitivity
- Mental retarded patients
- Patients with psychological disorders and neurologic sequel
- Additionally, patients who;
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Žádný zásah: Standard Treatment
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.
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Aktivní komparátor: Single point (P6) Acupuncture
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. |
A standardized acupuncture protocol will be administered
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Experimentální: Double point (P6+ST36) Acupuncture
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.
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A standardized acupuncture protocol will be administered
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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PONV prophylaxis
Časové okno: 12 months
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The frequency of PONV development
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12 months
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Postoperative anti-emetic requirement
Časové okno: 12 months
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The amount of anti-emetic agent administered postoperatively
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12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Apfel 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.
- 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. Erratum In: Anesth Analg. 2020 Nov;131(5):e241.
- Lee 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.
- Unsal 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.
- Usichenko 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.
- Bai 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.
- Lu 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.
- Sun 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.
- Xu 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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