Prevention of PONV With Traditional Chinese Medicine

ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Multicentre, Randomised, Double-Blind Controlled Trial.

Postoperative nausea and vomiting (PONV) is particularly one of the most common complications after laparoscopic sleeve gastrectomy (LSG). It can lead to serious adverse events and delayed activity, and prolong the time of rehabilitation and discharge. Numbers of studies have been focused on identifying risk factors and therapies of PONV. Unfortunately, there' no consistent comments for PONV prevention in women after LSG. Notably, Zusanli (ST36) acupoint and anisodamine have been evidenced to treat various gastrointestinal conditions. The primary outcome of this study was to evaluate the impact of anisodamine injection in ST36 on PONV in women following bariatric surgery.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Procedure: ST36 acupoint injection

Detailed Description

At the onset of this investigation, we have already identified several methodologic issues, such as the timing of the acupuncture intervention, sample size, perioperative anesthetic techniques, and appropriate control groups. All subjects were randomly assigned to the following two groups: ST36 acupoint injection group (bilateral ST36 acupoint injection with scopolamine); pharmacoprophylaxis group (bilateral ST36 injection with normal saline). The primary outcome of this study was the total incidence of PONV during the hospital and after the discharge. Participants were randomly assigned into different groups according to the computer-generated randomization sequence (http://www.randomization.com). Patients, surgeons, care givers, anesthesiologists, nursing staff, and outcomes assessor, were all blinded to the group assignment.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunxia Huang, Ph.D; Phone Number: +8613500512159; Email: huangchunxia@ahmu.edu.cn
• Study Contact Backup: Name: Qi Xue, Ph.D

Study Locations

• China
  • Beijing, China, 100020
    • Not yet recruiting
    • Beijing Chao-Yang Hospital, Capital Medical University
    • Contact: Rong Shi
  • Shanghai, China, 550001
    • Not yet recruiting
    • Huashan Hospital Affiliated to Fudan University
    • Contact: Qiong Yu, M.D, Ph.D
    • Contact: Beibei Wang
  • Anhui
    • Hefei, Anhui, China, 230601
      • Recruiting
      • The Second Hospital of Anhui Medical University
      • Contact: Chunxia Huang, Ph.D; Phone Number: +8613500512159; Email: huangchunxia@ahmu.edu.cn
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Not yet recruiting
      • The First Affiliated Hospital of Jinan University
      • Contact: Zhiyong Dong, M.D
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Not yet recruiting
      • Henan Provincial People's Hospital
      • Contact: Xu Wang
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Not yet recruiting
      • Jiangsu Province Hospital
      • Contact: Xuelong Zhou, M.D
    • Xuzhou, Jiangsu, China, 221004
      • Not yet recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Guanglei Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Female patients with an American Society of Anesthesia (ASA) physical status I-IV
2. Scheduled for elective bariatric surgery
3. Written informed consent was obtained

Exclusion Criteria:

1. Patients with contraindications for acupoint injection
2. Difficulty in communicating with patients
3. Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al)
4. Coagulation dysfunction
5. Pre-existing psychological or neurological disorder
6. Pre-use medicine before surgery that would interferenced objective assessment (including the use of opioids, antiemetics or glucocorticoids)
7. Gastroesophageal reflux disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ST36 acupoint injection group; Patients in this group will received bilateral ST36 injection with scopolamine 1ml/point	Procedure: ST36 acupoint injection; ST36 is located on the lateral surface of leg, 3 cun distal to the lower border of the patella, 1 finger-breadth lateral to the anterior crest of the tibia, between the tibialis anterior muscle and the tendon of the extensor digitorum longus. (The breadth of patient's middle finger was the proportional unit of measure "the cun", defined as the distance between the two medial ends of the creases of the interphalangeal joints when the patient's middle finger is flexed).
Placebo Comparator: pharmacoprophylaxis group; Patients in this group will received bilateral ST36 acupoint injection with normal saline 1ml/point	Procedure: ST36 acupoint injection; ST36 is located on the lateral surface of leg, 3 cun distal to the lower border of the patella, 1 finger-breadth lateral to the anterior crest of the tibia, between the tibialis anterior muscle and the tendon of the extensor digitorum longus. (The breadth of patient's middle finger was the proportional unit of measure "the cun", defined as the distance between the two medial ends of the creases of the interphalangeal joints when the patient's middle finger is flexed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and severity of PONV	The incidence and severity of PONV after bariatric surgery	At 0-2 hours after surgery
The incidence and severity of PONV	Total usage of rescue antiemetic drugs after bariatric surgery	At 2-6 hours after surgery
The incidence and severity of PONV	The incidence and severity of PONV after bariatric surgery	At 6-12 hours after surgery
The incidence and severity of PONV	The incidence and severity of PONV after bariatric surgery	At 12-24 hours after surgery
The usage of rescue antiemetic drugs	Total usage of rescue antiemetic drugs after bariatric surgery	During 3 months after bariatric surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
15-item Quality of Recovery(QoR-15)	QoR-15 will be used to evaluate recovery quality after anesthesia, including 15 items covering sleep, satisfaction, emotion and pain et. al,total score ranges from 0 to 150,the higher score means the higher quality of recovery.	Postoperative 24 hours
Postoperative pain	Patients will be asked about their pain level at rest and moving on a numeric rating scale (0=no pain,10=worst pain imaginable) .	At 0-24 and 24-72 hours after surgery
Consumption of analgesics	Cumulative analgesic consumption after surgery	During 3 months after bariatric surgery
Ambulation time	Interval time of patients' transit from bed rest to ambulation after surgery	Postoperative 1-3 days
Postoperative food and water intake time	Duration of eating and drinking after surgery	Postoperative 1-3 days
Postoperative hospitalization duration	Days of hospital staying after surgery	2 weeks after surgery
Pittsburgh sleep quality index	Pittsburgh sleep quality index will be used to evaluate quality of sleep. The higher score means the lower quality of sleep.	Before surgery and at postoperative 3 months
Gastrointestinal Symptom Rating Scale	Gastrointestinal symptom rating scale (GSRS) will be used to assess gastrointestinal function. The score ranges from 0 to 45. The higher score means poorer gastrointestinal function .	Before surgery and at postoperative 3 months
Hamilton depression rating scale	Hamilton depression scale (HAMD) will be used to assess depression. HAMD 24 item version score range 0-96. The higher score means the higher possibility of depression.	Before surgery and at postoperative 3 months
Hamilton anxiety rating scale	Hamilton anxiety scale (HAM-A) will be used to assess anxiety. Total score ranges from 0 to 56, the higher the score is, the more serious the anxiety is.	Before surgery and at postoperative 3 months
The MOS item short from health survey ,SF-36	Concise health status scale	Before surgery and at the postoperative 3 months.The scale consists of 36 items，divided into 8 sections，score of each section ranges from 0 to 100, the higher the score is, the healthier is.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of propofol	The total consumption of propofol during the surgery	During the bariatric surgery
Consumption of remifentanil	The total consumption of remifentanil during the surgery	During the surgery
Consumption of sufentanil	The total consumption of sufentanil during the surgery	During the surgery and postoperative 1-3 days
Duration of anesthesia	From beginning to the end of anesthesia	At the end of anesthesia
Duration of surgery	From beginning to the end of surgery	At the end of surgery

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Huashan Hospital; Beijing Chao Yang Hospital; Henan Provincial People's Hospital; First Affiliated Hospital of Jinan University; The Affiliated Hospital of Xuzhou Medical University
• Investigators: Principal Investigator: Ye Zhang, M.D, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; postoperative nausea and vomiting; Zusanli; anisodamine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: YX2021-152（F1）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlie results in a publication are to be shared with other researchers.
• IPD Sharing Time Frame: The IPD will become available when summary data are published.
• IPD Sharing Access Criteria: ChunXia Huang and Ye Zhang will review requests and criteria to share IPD. Requests are to be sent by email to huangchunxia@ahmu.edu.cn or zhangye_hassan@sina.com.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No