NCT05240482

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

January 10, 2022

Last Update Submit

July 13, 2022

Conditions

Postoperative Nausea and Vomiting

Keywords

postoperative nausea and vomitingbariatric surgeryZusanli (ST36)anisodamine

Outcome Measures

Primary Outcomes (1)

  • The incidence of PONV within the first 24 hours

    The incidence of PONV within the first 24 hours

    At 0-24 hours after surgery

Secondary Outcomes (18)

  • Time to the first rescue antiemetics

    At 0-24 hours after surgery

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

    At 0-24 hours after surgery

  • Early recovery outcomes

    Before discharge

  • Consumption of propofol

    During the surgery

  • Consumption of remifentanil

    During the surgery

  • +13 more secondary outcomes

Study Arms (2)

Conventional treatment group

PLACEBO COMPARATOR

Patients in the placebo group will receive bilateral ST36 injection with normal saline 1ml/point

Procedure: ST36 acupuncture

ST36 acupoint injection group

EXPERIMENTAL

Patients in the experimental group will receive bilateral ST36 injection with anisodamine 1ml/point

Procedure: ST36 acupuncture

Interventions

ST36 acupuncturePROCEDURE

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).

Conventional treatment groupST36 acupoint injection 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-Ⅲ
  • Scheduled for elective bariatric surgery .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Anhui Medical University

Hefei, 230601, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Ye Zhang, M.D.

    The Second Hospital of Anhui Medical University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 15, 2022

Study Start

February 20, 2022

Primary Completion

May 10, 2022

Study Completion

July 6, 2022

Last Updated

July 15, 2022

Record last verified: 2022-07

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(1)