Postoperative Nausea and VomitingNCT05375721
Prevention of PONV With Traditional Chinese Medicine
A study testing ST36 acupoint injection in people with Postoperative Nausea and Vomiting, run by The Second Hospital of Anhui Medical University at 7 sites in China.
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. 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 acupoint injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 7 sitesChina
- Study dates
- 23 Sep 2022to 1 May 2024
- 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-IV
- Scheduled for elective bariatric surgery
- Written informed consent was obtained
Who cannot join
- Patients with contraindications for acupoint injection
- Difficulty in communicating with patients
- Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al)
- Coagulation dysfunction
- Pre-existing psychological or neurological disorder
- Pre-use medicine before surgery that would interferenced objective assessment (including the use of opioids, antiemetics or glucocorticoids)
- Gastroesophageal reflux disease
Trial locations and contacts
7 sites in 1 country.
Qi Xue, Ph.D contact
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, 100020
Rong Shi
- Not yet recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Zhiyong Dong, M.D
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Chunxia Huang, Ph.D, +8613500512159, huangchunxia@ahmu.edu.cn
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Xuelong Zhou, M.D
- Not yet recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, 550001
Qiong Yu, M.D, Ph.D
Beibei Wang
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004
Guanglei Wang
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Xu Wang
About this study
Official title: ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Multicentre, Randomised, Double-Blind Controlled Trial.
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.
Read the detailed 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- ST36 acupoint injection
- Keywords
- postoperative nausea and vomiting, bariatric surgery, Zusanli, anisodamine, obesity
- Medical subject headings
- Postoperative Nausea and Vomiting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST36 acupoint injectionProcedure 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 |
|---|---|---|
| ST36 acupoint injection group | Experimental | Patients in this group will received bilateral ST36 injection with scopolamine 1ml/point Receives: Procedure: ST36 acupoint injection |
| pharmacoprophylaxis group | Placebo comparator | Patients in this group will received bilateral ST36 acupoint injection with normal saline 1ml/point Receives: Procedure: ST36 acupoint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of PONV
The incidence and severity of PONV after bariatric surgery
Measured: At 0-2 hours after surgery
The incidence and severity of PONV
Total usage of rescue antiemetic drugs after bariatric surgery
Measured: At 2-6 hours after surgery
The incidence and severity of PONV
The incidence and severity of PONV after bariatric surgery
Measured: At 6-12 hours after surgery
The incidence and severity of PONV
The incidence and severity of PONV after bariatric surgery
Measured: At 12-24 hours after surgery
The usage of rescue antiemetic drugs
Total usage of rescue antiemetic drugs after bariatric surgery
Measured: During 3 months after bariatric surgery
Secondary outcomes (11)
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.
Measured: Postoperative 24 hours
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) .
Measured: At 0-24 and 24-72 hours after surgery
Consumption of analgesics
Cumulative analgesic consumption after surgery
Measured: During 3 months after bariatric surgery
Ambulation time
Interval time of patients' transit from bed rest to ambulation after surgery
Measured: Postoperative 1-3 days
Postoperative food and water intake time
Duration of eating and drinking after surgery
Measured: Postoperative 1-3 days
Postoperative hospitalization duration
Days of hospital staying after surgery
Measured: 2 weeks after surgery
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.
Measured: Before surgery and at 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 postoperative 3 months
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.
Measured: Before surgery and at postoperative 3 months
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.
Measured: Before surgery and at postoperative 3 months
The MOS item short from health survey ,SF-36
Concise health status scale
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start23 Sep 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Huashan Hospital, Henan Provincial People's Hospital, The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Jinan University, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, hui hou, The Second Hospital of Anhui Medical University
- Investigators
- Ye Zhang, M.D, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375721
- Sponsor's protocol ID
- YX2021-152（F1）
- Status last verified
- Sep 2022
- First submitted
- 22 Apr 2022
- Last updated
- 23 Sep 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 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ST36 Acupoint Injection With Anisodamine for Postoperative Nausea and Vomiting in Women Following Bariatric Surgery: A Multicentre, Randomised, Double-Blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT05375721
- Acronym / sponsor ID
- YX2021-152（F1）
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- postoperative nausea and vomiting, bariatric surgery, Zusanli, anisodamine, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Huashan Hospital, Henan Provincial People's Hospital, The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Jinan University, Beijing Chao Yang Hospital
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 17 May 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 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.
Detailed 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.
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 |
|---|---|---|
| ST36 acupoint injection group | Experimental | Procedure: ST36 acupoint injectionPatients in this group will received bilateral ST36 injection with scopolamine 1ml/point |
| pharmacoprophylaxis group | Placebo comparator | Procedure: ST36 acupoint injectionPatients in this group will received bilateral ST36 acupoint injection with normal saline 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 (3 listed)
- Female patients with an American Society of Anesthesia (ASA) physical status I-IV
- Scheduled for elective bariatric surgery
- Written informed consent was obtained
Key exclusion criteria (7 listed)
- Patients with contraindications for acupoint injection
- Difficulty in communicating with patients
- Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al)
- Coagulation dysfunction
- Pre-existing psychological or neurological disorder
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 acupoint injectionST36 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 | ST36 acupoint injection group, pharmacoprophylaxis group |
Primary outcome
The incidence and severity of PONV
Time frame: At 0-2 hours after surgery
The incidence and severity of PONV after bariatric surgery
The incidence and severity of PONV
Time frame: At 2-6 hours after surgery
Total usage of rescue antiemetic drugs after bariatric surgery
The incidence and severity of PONV
Time frame: At 6-12 hours after surgery
The incidence and severity of PONV after bariatric surgery
The incidence and severity of PONV
Time frame: At 12-24 hours after surgery
The incidence and severity of PONV after bariatric surgery
The usage of rescue antiemetic drugs
Time frame: During 3 months after bariatric surgery
Total usage of rescue antiemetic drugs after bariatric surgery
11 secondary outcomes
15-item Quality of Recovery(QoR-15)
Time frame: Postoperative 24 hours
Postoperative pain
Time frame: At 0-24 and 24-72 hours after surgery
Consumption of analgesics
Time frame: During 3 months after bariatric surgery
Ambulation time
Time frame: Postoperative 1-3 days
Postoperative food and water intake time
Time frame: Postoperative 1-3 days
Postoperative hospitalization duration
Time frame: 2 weeks after surgery
Pittsburgh sleep quality index
Time frame: Before surgery and at postoperative 3 months
Gastrointestinal Symptom Rating Scale
Time frame: Before surgery and at postoperative 3 months
Hamilton depression rating scale
Time frame: Before surgery and at postoperative 3 months
Hamilton anxiety rating scale
Time frame: Before surgery and at postoperative 3 months
The MOS item short from health survey ,SF-36
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
Qi Xue, Ph.D contact
Ye Zhang, M.D principal investigator
The Second Hospital of Anhui Medical University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ST36 acupoint injection in people with Postoperative Nausea and Vomiting, run by The Second Hospital of Anhui Medical University at 7 sites 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunxia Huang, Ph.D (+8613500512159, huangchunxia@ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of PONV (time frame: At 0-2 hours after surgery). The study lists 5 primary outcomes in all. 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 23 Sep 2022.