Prevention of PONV With Traditional Chinese Medicine

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375721
• Other study ID #: YX2021-152(F1)
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2022
• Source: The Second Hospital of Anhui Medical University
• Contact: Chunxia Huang, Ph.D
• Phone: +8613500512159
• Email: huangchunxia[@]ahmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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).

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Huashan Hospital Affiliated to Fudan University	Shanghai
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (7)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University	Beijing Chao Yang Hospital, First Affiliated Hospital of Jinan University, Henan Provincial People's Hospital, Huashan Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Consumption of propofol	The total consumption of propofol during the surgery	During the bariatric surgery
Other	Consumption of remifentanil	The total consumption of remifentanil during the surgery	During the surgery
Other	Consumption of sufentanil	The total consumption of sufentanil during the surgery	During the surgery and postoperative 1-3 days
Other	Duration of anesthesia	From beginning to the end of anesthesia	At the end of anesthesia
Other	Duration of surgery	From beginning to the end of surgery	At the end of surgery
Primary	The incidence and severity of PONV	The incidence and severity of PONV after bariatric surgery	At 0-2 hours after surgery
Primary	The incidence and severity of PONV	Total usage of rescue antiemetic drugs after bariatric surgery	At 2-6 hours after surgery
Primary	The incidence and severity of PONV	The incidence and severity of PONV after bariatric surgery	At 6-12 hours after surgery
Primary	The incidence and severity of PONV	The incidence and severity of PONV after bariatric surgery	At 12-24 hours after surgery
Primary	The usage of rescue antiemetic drugs	Total usage of rescue antiemetic drugs after bariatric surgery	During 3 months after bariatric surgery
Secondary	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
Secondary	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
Secondary	Consumption of analgesics	Cumulative analgesic consumption after surgery	During 3 months after bariatric surgery
Secondary	Ambulation time	Interval time of patients' transit from bed rest to ambulation after surgery	Postoperative 1-3 days
Secondary	Postoperative food and water intake time	Duration of eating and drinking after surgery	Postoperative 1-3 days
Secondary	Postoperative hospitalization duration	Days of hospital staying after surgery	2 weeks after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.