ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240482
• Other study ID #: YX2021-114
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: July 6, 2022

Study information

• Verified date: July 2022
• Source: The Second Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 6, 2022
• Est. primary completion date: May 10, 2022
• 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 ?-?

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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).

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Anhui Medical University	Hefei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to the first rescue antiemetics	The time from extubation to the first rescue antiemetics	At 0-24 hours after surgery
Secondary	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
Secondary	Early recovery outcomes	Including the time of first drink, ambulate and flatus	Before discharge
Secondary	Consumption of propofol	The consumption of propofol during the surgery	During the surgery
Secondary	Consumption of remifentanil	The consumption of remifentanil during the surgery	During the surgery
Secondary	Consumption of cisatracurium	The consumption of cisatracurium during the surgery	During the surgery
Secondary	Consumption of dexmedetomidine	The consumption of cisatracurium during the surgery	During the surgery
Secondary	Length of anesthesia	From beginning to the end of anesthesia	At the end of anesthesia
Secondary	Length of surgery	From beginning to the end of surgery	At the end of surgery
Secondary	Postoperative hospitalization	Days of hospital staying after surgery	During hospital
Secondary	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
Secondary	The usage of rescue antiemetic drugs	Total usage of rescue antiemetic drugs after surgery	Within 24 hours after surgery in anesthesia resuscitation unit
Secondary	Adverse events	Any adverse events after surgery within postoperative 3 months	Within 3 months after surgery
Secondary	BMI	Body mass index	Before surgery and at the postoperative 3 months
Secondary	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
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 the postoperative 3 months
Secondary	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
Secondary	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