Acupuncture for Prevention of Postoperative Nausea and Vomiting

NCT04866121 | Unknown

• 1 other identifier: 14.04.2021/28
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

PONV

Keywords

PONV; P6 Acupuncture; ST36 Acupuncture

Outcome Measures

Primary Outcomes (2)

• PONV prophylaxis

  The frequency of PONV development

  12 months

• Postoperative anti-emetic requirement

  The amount of anti-emetic agent administered postoperatively

  12 months

Study Arms (3)

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.

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.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

A standardized acupuncture protocol will be administered

Double point (P6+ST36) Acupuncture; Single point (P6) Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Laparoscopic cholecystectomy is performed far more in women than in men with a ratio of 5:1. Additionally, being women is one of the major risk factors for PONV development.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between 18-65 years old, who have ASA scores of I-II-III and who are planned to undergo elective laparoscopic cholecystectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Training and Research Hospital

Niğde, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• 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.

  PMID: 32467512 BACKGROUND

• 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.

  PMID: 31580707 BACKGROUND

• 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.

  PMID: 23035051 BACKGROUND

• 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.

  PMID: 26522652 BACKGROUND

• 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.

  PMID: 26286527 BACKGROUND

• 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.

  PMID: 29921161 BACKGROUND

• 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.

  PMID: 31148903 BACKGROUND

• 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.

  PMID: 31359627 BACKGROUND

• 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.

  PMID: 30843420 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Alirıza Erdoğan, MD

CONTACT

05333558377; alirizaerdogan@ohu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)