NCT05375721

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 23, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

April 22, 2022

Last Update Submit

September 22, 2022

Conditions

Postoperative Nausea and Vomiting

Keywords

postoperative nausea and vomitingbariatric surgeryZusanlianisodamineobesity

Outcome Measures

Primary Outcomes (5)

  • The incidence and severity of PONV

    The incidence and severity of PONV after bariatric surgery

    At 0-2 hours after surgery

  • The incidence and severity of PONV

    Total usage of rescue antiemetic drugs after bariatric surgery

    At 2-6 hours after surgery

  • The incidence and severity of PONV

    The incidence and severity of PONV after bariatric surgery

    At 6-12 hours after surgery

  • The incidence and severity of PONV

    The incidence and severity of PONV after bariatric surgery

    At 12-24 hours after surgery

  • The usage of rescue antiemetic drugs

    Total usage of rescue antiemetic drugs after bariatric surgery

    During 3 months after bariatric surgery

Secondary Outcomes (11)

  • 15-item Quality of Recovery(QoR-15)

    Postoperative 24 hours

  • Postoperative pain

    At 0-24 and 24-72 hours after surgery

  • Consumption of analgesics

    During 3 months after bariatric surgery

  • Ambulation time

    Postoperative 1-3 days

  • Postoperative food and water intake time

    Postoperative 1-3 days

  • +6 more secondary outcomes

Other Outcomes (5)

  • Consumption of propofol

    During the bariatric surgery

  • Consumption of remifentanil

    During the surgery

  • Consumption of sufentanil

    During the surgery and postoperative 1-3 days

  • +2 more other outcomes

Study Arms (2)

ST36 acupoint injection group

EXPERIMENTAL

Patients in this group will received bilateral ST36 injection with scopolamine 1ml/point

Procedure: ST36 acupoint injection

pharmacoprophylaxis group

PLACEBO COMPARATOR

Patients in this group will received bilateral ST36 acupoint injection with normal saline 1ml/point

Procedure: ST36 acupoint injection

Interventions

ST36 acupoint injectionPROCEDURE

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).

ST36 acupoint injection grouppharmacoprophylaxis group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with an American Society of Anesthesia (ASA) physical status I-IV
  • Scheduled for elective bariatric surgery
  • Written informed consent was obtained

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China

NOT YET RECRUITING

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, 100020, China

NOT YET RECRUITING

Huashan Hospital Affiliated to Fudan University

Shanghai, 550001, China

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and VomitingObesity

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Ye Zhang, M.D

    The Second Hospital of Anhui Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunxia Huang, Ph.D

CONTACT

+8613500512159huangchunxia@ahmu.edu.cn

Qi Xue, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 17, 2022

Study Start

September 23, 2022

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication are to be shared with other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The IPD will become available when summary data are published.
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.

Locations

CN(7)