PONV Clinical Trial
— PONVOfficial title:
The Comparison of P6+ST36 Combination Acupuncture Therapy With P6 Alone Acupuncture and Standard Treatment in Postoperative Nausea and Vomiting
NCT number | NCT04866121 |
Other study ID # | 14.04.2021/28 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | May 1, 2022 |
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.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Nigde Ömer Halisdemir University Training and Research Hospital | Nigde |
Lead Sponsor | Collaborator |
---|---|
Nigde Omer Halisdemir University |
Turkey,
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. — View 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. — View Citation
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. Review. Erratum in: Anesth Analg. 2020 Nov;131(5):e241. — View Citation
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;(11):CD003281. doi: 10.1002/14651858.CD003281.pub4. Review. — View 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PONV prophylaxis | The frequency of PONV development | 12 months | |
Primary | Postoperative anti-emetic requirement | The amount of anti-emetic agent administered postoperatively | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01945502 -
Nasopharyngeal Packing and Rhinologic Surgery.
|
N/A | |
Completed |
NCT01840254 -
Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial
|
N/A | |
Completed |
NCT00760253 -
Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients
|
N/A | |
Completed |
NCT00772226 -
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
|
Phase 3 | |
Recruiting |
NCT03783182 -
Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy
|
Phase 4 | |
Recruiting |
NCT03835234 -
Incidence and Factors Associated With PONV in Regional Anaesthesia
|
||
Recruiting |
NCT04191694 -
Chewing Gum to Prevent Nausea and Vomiting After Caesarean Section Under Spinal Anaesthesia
|
N/A | |
Completed |
NCT02468323 -
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia
|
Phase 4 | |
Recruiting |
NCT05596695 -
Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting
|
N/A | |
Recruiting |
NCT04570592 -
Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting
|
Phase 2 | |
Completed |
NCT02116257 -
The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV
|
N/A | |
Not yet recruiting |
NCT05396716 -
Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
|
N/A | |
Active, not recruiting |
NCT00892996 -
Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
|
N/A | |
Completed |
NCT02809378 -
The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV
|
Phase 4 | |
Completed |
NCT05408676 -
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
|
N/A | |
Completed |
NCT01991821 -
European Phase III Study of APD421 in PONV
|
Phase 3 | |
Completed |
NCT00952133 -
Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
|
Phase 4 | |
Completed |
NCT04054479 -
Penehyclidine for PONV Prophylaxis After Strabismus Surgery
|
Phase 4 | |
Completed |
NCT05540236 -
Effects of Auricular Acupressure on the Management of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgeries
|
N/A | |
Completed |
NCT03278522 -
Ramosetron Pre-treatment for PONV and QT Prolongation
|
Phase 4 |