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NCT Number: NCT05240482

ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital of Anhui Medical University

Hefei, 230601, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients with an American Society of Anesthesia (ASA) physical status Ⅰ-Ⅲ
  • Scheduled for elective bariatric surgery .

Exclusion criteria

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

Treatment and study plan

ST36 acupuncture

Procedure

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).

Primary outcomes

  1. The incidence of PONV within the first 24 hours

    Time frame: At 0-24 hours after surgery

    The incidence of PONV within the first 24 hours

Secondary outcomes

  1. Time to the first rescue antiemetics

    Time frame: At 0-24 hours after surgery

    The time from extubation to the first rescue antiemetics

  2. The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery

    Time frame: At 0-24 hours after surgery

    The incidence and severity of PONV in the anesthesia intensive care unit (AICU) or during the ward.

  3. Early recovery outcomes

    Time frame: Before discharge

    Including the time of first drink, ambulate and flatus

  4. Consumption of propofol

    Time frame: During the surgery

    The consumption of propofol during the surgery

  5. Consumption of remifentanil

    Time frame: During the surgery

    The consumption of remifentanil during the surgery

  6. Consumption of cisatracurium

    Time frame: During the surgery

    The consumption of cisatracurium during the surgery

  7. Consumption of dexmedetomidine

    Time frame: During the surgery

    The consumption of cisatracurium during the surgery

  8. Length of anesthesia

    Time frame: At the end of anesthesia

    From beginning to the end of anesthesia

  9. Length of surgery

    Time frame: At the end of surgery

    From beginning to the end of surgery

  10. Postoperative hospitalization

    Time frame: During hospital

    Days of hospital staying after surgery

  11. QoR-15

    Time frame: At 24 hours after surgery

    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.

  12. The usage of rescue antiemetic drugs

    Time frame: Within 24 hours after surgery in anesthesia resuscitation unit

    Total usage of rescue antiemetic drugs after surgery

  13. Adverse events

    Time frame: Within 3 months after surgery

    Any adverse events after surgery within postoperative 3 months

  14. BMI

    Time frame: Before surgery and at the postoperative 3 months

    Body mass index

  15. Pittsburgh Sleep Quality Index

    Time frame: Before surgery and at the postoperative 3 months

    Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep.

  16. Gastrointestinal Symptom Rating Scale

    Time frame: Before surgery and at the postoperative 3 months

    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 .

  17. Hamilton Depression Rating Scale

    Time frame: Before surgery and at the postoperative 3 months

    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.

  18. Hamilton Anxiety Rating Scale

    Time frame: Before surgery and at the postoperative 3 months

    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.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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