ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ST36 acupuncture
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring postoperative nausea and vomiting, bariatric surgery, Zusanli (ST36), anisodamine
Eligibility Criteria
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
Sites / Locations
- Second Affiliated Hospital of Anhui Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Conventional treatment group
ST36 acupoint injection group
Arm Description
Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point
Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point
Outcomes
Primary Outcome Measures
The incidence of PONV within the first 24 hours
The incidence of PONV within the first 24 hours
Secondary Outcome Measures
Time to the first rescue antiemetics
The time from extubation to the first rescue antiemetics
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.
Early recovery outcomes
Including the time of first drink, ambulate and flatus
Consumption of propofol
The consumption of propofol during the surgery
Consumption of remifentanil
The consumption of remifentanil during the surgery
Consumption of cisatracurium
The consumption of cisatracurium during the surgery
Consumption of dexmedetomidine
The consumption of cisatracurium during the surgery
Length of anesthesia
From beginning to the end of anesthesia
Length of surgery
From beginning to the end of surgery
Postoperative hospitalization
Days of hospital staying after surgery
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.
The usage of rescue antiemetic drugs
Total usage of rescue antiemetic drugs after surgery
Adverse events
Any adverse events after surgery within postoperative 3 months
BMI
Body mass index
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.
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 .
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.
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.
Full Information
NCT ID
NCT05240482
First Posted
January 10, 2022
Last Updated
July 13, 2022
Sponsor
The Second Hospital of Anhui Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05240482
Brief Title
ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting
Official Title
Zusanli (ST36) Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Single-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Anhui Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
postoperative nausea and vomiting, bariatric surgery, Zusanli (ST36), anisodamine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Outcomes will be evaluated by anesthesiologists who are blinded to the treatment allocation. Patients, investigators and observers will be blinded to the patient allocation throughout the entire study period.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment group
Arm Type
Placebo Comparator
Arm Description
Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point
Arm Title
ST36 acupoint injection group
Arm Type
Experimental
Arm Description
Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point
Intervention Type
Procedure
Intervention Name(s)
ST36 acupuncture
Intervention Description
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 Outcome Measure Information:
Title
The incidence of PONV within the first 24 hours
Description
The incidence of PONV within the first 24 hours
Time Frame
At 0-24 hours after surgery
Secondary Outcome Measure Information:
Title
Time to the first rescue antiemetics
Description
The time from extubation to the first rescue antiemetics
Time Frame
At 0-24 hours after surgery
Title
The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery
Description
The incidence and severity of PONV in the anesthesia intensive care unit (AICU) or during the ward.
Time Frame
At 0-24 hours after surgery
Title
Early recovery outcomes
Description
Including the time of first drink, ambulate and flatus
Time Frame
Before discharge
Title
Consumption of propofol
Description
The consumption of propofol during the surgery
Time Frame
During the surgery
Title
Consumption of remifentanil
Description
The consumption of remifentanil during the surgery
Time Frame
During the surgery
Title
Consumption of cisatracurium
Description
The consumption of cisatracurium during the surgery
Time Frame
During the surgery
Title
Consumption of dexmedetomidine
Description
The consumption of cisatracurium during the surgery
Time Frame
During the surgery
Title
Length of anesthesia
Description
From beginning to the end of anesthesia
Time Frame
At the end of anesthesia
Title
Length of surgery
Description
From beginning to the end of surgery
Time Frame
At the end of surgery
Title
Postoperative hospitalization
Description
Days of hospital staying after surgery
Time Frame
During hospital
Title
QoR-15
Description
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.
Time Frame
At 24 hours after surgery
Title
The usage of rescue antiemetic drugs
Description
Total usage of rescue antiemetic drugs after surgery
Time Frame
Within 24 hours after surgery in anesthesia resuscitation unit
Title
Adverse events
Description
Any adverse events after surgery within postoperative 3 months
Time Frame
Within 3 months after surgery
Title
BMI
Description
Body mass index
Time Frame
Before surgery and at the postoperative 3 months
Title
Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep.
Time Frame
Before surgery and at the postoperative 3 months
Title
Gastrointestinal Symptom Rating Scale
Description
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 .
Time Frame
Before surgery and at the postoperative 3 months
Title
Hamilton Depression Rating Scale
Description
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.
Time Frame
Before surgery and at the postoperative 3 months
Title
Hamilton Anxiety Rating Scale
Description
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.
Time Frame
Before surgery and at the postoperative 3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Zhang, M.D.
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230601
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting
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