ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting

Zusanli (ST36) Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Single-center Study

Postoperative nausea and vomiting (PONV) is particularly distressing although it is not a fatal postoperative complication. 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 laparoscopic sleeve gastrectomy. 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: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Procedure: ST36 acupuncture

Detailed Description

Acupuncture has been used as a medical technique in China for at least 2,000 years. More recently, it's also been extensively used in managing headache, chronic back pain, and PONV in USA. ST36 acupuncture is reported to be an effective preventive treatment for postoperative nausea and vomiting (PONV). However, It is not clear if it could efficiently prevent PONV in female patient who has underwent bariatric surgery. 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. 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 with a computer-generated randomization sequence (http://www.randomization.com). Patients, surgeons, anesthesiologists, nursing staff, and the research assistant, were all blinded to the group assignment.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hefei, China, 230601
    • Second Affiliated hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 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-Ⅲ
2. Scheduled for elective bariatric surgery .

Exclusion Criteria:

1. lack of patient consent
2. patients with contraindications for acupoint injection
3. obesity due to endocrine disorder
4. allergic diathesis for drugs used in the study
5. serious illness (heart, lung, kidney, or liver)
6. coagulation dysfunction
7. pre-existing psychological disorder
8. anticathartic , glucocorticoid or opiates medications

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
Placebo Comparator: Conventional treatment group; Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point	Procedure: ST36 acupuncture; 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).
Experimental: ST36 acupoint injection group; Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point	Procedure: ST36 acupuncture; 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 of PONV within the first 24 hours	The incidence of PONV within the first 24 hours	At 0-24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first rescue antiemetics	The time from extubation to the first rescue antiemetics	At 0-24 hours after surgery
The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery	The incidence and severity of PONV in the anesthesia intensive care unit (AICU) or during the ward.	At 0-24 hours after surgery
Early recovery outcomes	Including the time of first drink, ambulate and flatus	Before discharge
Consumption of propofol	The consumption of propofol during the surgery	During the surgery
Consumption of remifentanil	The consumption of remifentanil during the surgery	During the surgery
Consumption of cisatracurium	The consumption of cisatracurium during the surgery	During the surgery
Consumption of dexmedetomidine	The consumption of cisatracurium during the surgery	During the surgery
Length of anesthesia	From beginning to the end of anesthesia	At the end of anesthesia
Length of surgery	From beginning to the end of surgery	At the end of surgery
Postoperative hospitalization	Days of hospital staying after surgery	During hospital
QoR-15	Quality of Recovery-15 (QoR-15) will be used to assess quality of recovery after anesthesia. Total score ranges from 0 to 150. A higher total score means better quality of recovery.	At 24 hours after surgery
The usage of rescue antiemetic drugs	Total usage of rescue antiemetic drugs after surgery	Within 24 hours after surgery in anesthesia resuscitation unit
Adverse events	Any adverse events after surgery within postoperative 3 months	Within 3 months after surgery
BMI	Body mass index	Before surgery and at the postoperative 3 months
Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep.	Before surgery and at the 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 the postoperative 3 months
Hamilton Depression Rating Scale	Hamilton Depression Rating 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 the postoperative 3 months
Hamilton Anxiety Rating Scale	Hamilton Anxiety Rating 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 the postoperative 3 months

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University
• Investigators: Study Chair: Ye Zhang, M.D., The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: February 12, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: bariatric surgery; postoperative nausea and vomiting; Zusanli (ST36); anisodamine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: YX2021-114

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