Postoperative Nausea and VomitingNCT05240482
ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting
A study testing ST36 acupuncture in people with Postoperative Nausea and Vomiting, run by The Second Hospital of Anhui Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- ST36 acupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2022to 6 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with an American Society of Anesthesia (ASA) physical status Ⅰ-Ⅲ
- Scheduled for elective bariatric surgery .
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Anhui Medical University
Hefei, 230601
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- ST36 acupuncture
- Keywords
- postoperative nausea and vomiting, bariatric surgery, Zusanli (ST36), anisodamine
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST36 acupunctureProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Placebo comparator | Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point Receives: Procedure: ST36 acupuncture |
| ST36 acupoint injection group | Experimental | Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point Receives: Procedure: ST36 acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PONV within the first 24 hours
The incidence of PONV within the first 24 hours
Measured: At 0-24 hours after surgery
Secondary outcomes (18)
Time to the first rescue antiemetics
The time from extubation to the first rescue antiemetics
Measured: 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.
Measured: At 0-24 hours after surgery
Early recovery outcomes
Including the time of first drink, ambulate and flatus
Measured: Before discharge
Consumption of propofol
The consumption of propofol during the surgery
Measured: During the surgery
Consumption of remifentanil
The consumption of remifentanil during the surgery
Measured: During the surgery
Consumption of cisatracurium
The consumption of cisatracurium during the surgery
Measured: During the surgery
Consumption of dexmedetomidine
The consumption of cisatracurium during the surgery
Measured: During the surgery
Length of anesthesia
From beginning to the end of anesthesia
Measured: At the end of anesthesia
Length of surgery
From beginning to the end of surgery
Measured: At the end of surgery
Postoperative hospitalization
Days of hospital staying after surgery
Measured: 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.
Measured: At 24 hours after surgery
The usage of rescue antiemetic drugs
Total usage of rescue antiemetic drugs after surgery
Measured: Within 24 hours after surgery in anesthesia resuscitation unit
Adverse events
Any adverse events after surgery within postoperative 3 months
Measured: Within 3 months after surgery
BMI
Body mass index
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: Before surgery and at the postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start20 Feb 2022
- Primary completion10 May 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hui hou, The Second Hospital of Anhui Medical University
- Investigators
- Ye Zhang, M.D., Study chair, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240482
- Sponsor's protocol ID
- YX2021-114
- Status last verified
- Jul 2022
- First submitted
- 10 Jan 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zusanli (ST36) Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Single-center Study
- ClinicalTrials.gov ID
- NCT05240482
- Acronym / sponsor ID
- YX2021-114
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- postoperative nausea and vomiting, bariatric surgery, Zusanli (ST36), anisodamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Placebo comparator | Procedure: ST36 acupuncturePatients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point |
| ST36 acupoint injection group | Experimental | Procedure: ST36 acupuncturePatients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients with an American Society of Anesthesia (ASA) physical status Ⅰ-Ⅲ
- Scheduled for elective bariatric surgery .
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST36 acupunctureST36 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). | Procedure or surgery | Conventional treatment group, ST36 acupoint injection group |
Primary outcome
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
18 secondary outcomes
Time to the first rescue antiemetics
Time frame: At 0-24 hours after surgery
The incidence and severity of PONV assessed at 2, 6, 48, and 72 hours after surgery
Time frame: At 0-24 hours after surgery
Early recovery outcomes
Time frame: Before discharge
Consumption of propofol
Time frame: During the surgery
Consumption of remifentanil
Time frame: During the surgery
Consumption of cisatracurium
Time frame: During the surgery
Consumption of dexmedetomidine
Time frame: During the surgery
Length of anesthesia
Time frame: At the end of anesthesia
Length of surgery
Time frame: At the end of surgery
Postoperative hospitalization
Time frame: During hospital
QoR-15
Time frame: At 24 hours after surgery
The usage of rescue antiemetic drugs
Time frame: Within 24 hours after surgery in anesthesia resuscitation unit
Adverse events
Time frame: Within 3 months after surgery
BMI
Time frame: Before surgery and at the postoperative 3 months
Pittsburgh Sleep Quality Index
Time frame: Before surgery and at the postoperative 3 months
Gastrointestinal Symptom Rating Scale
Time frame: Before surgery and at the postoperative 3 months
Hamilton Depression Rating Scale
Time frame: Before surgery and at the postoperative 3 months
Hamilton Anxiety Rating Scale
Time frame: Before surgery and at the postoperative 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication are to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Zhang, M.D. study chair
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ST36 acupuncture in people with Postoperative Nausea and Vomiting, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PONV within the first 24 hours (time frame: At 0-24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.