Clinical trial NCT04866121: Acupuncture for Prevention of Postoperative Nausea and Vomiting
Official title: The Comparison of P6+ST36 Combination Acupuncture Therapy With P6 Alone Acupuncture and Standard Treatment in Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PONV
Keywords: PONV
P6 Acupuncture
ST36 Acupuncture
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PONV prophylaxis
timeFrame: 12 months
measure: Postoperative anti-emetic requirement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Niğde Ömer Halisdemir University Training and Research Hospital
Study officials:
References:
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citation: 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.
citation: 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.
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