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Effect of SmtO2 Guided Care on PONV (iMODIPONV)

NCT03641625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2019-09-25

No results posted yet for this study

Summary

This randomized controlled trial is to investigate if SmtO2-guided management on top of the usual care, compared with the usual care only, during laparoscopic hysterectomy significantly reduces the incidence of PONV.

Conditions

  • Postoperative Nausea and Vomiting
  • Hysterectomy
  • Tissue Oxygenation
  • Cardiac Output Management
  • Blood Pressure Management

Interventions

DEVICE

Muscular tissue oxygen saturation guided care

Muscular tissue oxygen saturation monitored at flank and arm will be maintained \> 70% (absolute measurement) and \> baseline throughout the entire procedure.

Sponsors & Collaborators

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Peking University Third Hospital

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Beijing Obstetrics and Gynecology Hospital

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Lingzhong Meng, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2019-06-29
Completion
2019-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641625 on ClinicalTrials.gov