Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE (NIDP)

September 11, 2021 updated by: diansan su, RenJi Hospital

Laryngomicrosurgery Under Nonintubated Deep Paralysis (NIDP) General Anesthesia Supported by Transnasal Humidified Rapid-insufflation Ventilatory Exchange: A Case Series Study

Laryngomicrosurgery requires deep paralysis and general anesthesia to finish the procedure. After the procedure, patients need a long time to recover. In the present study, with the support of the transnasal humidified rapid-insufflation ventilatory exchange, laryngomicrosurgery would be finished under nonintubated deep paralysis (NIDP) general anesthesia. In this case series study, the investigators will test the safety and feasibility of such a technique.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yichen Fan, M.S.
  • Phone Number: ＋86 13482827569
  • Email: mcking95@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Young patients who will under elective polypectomy of unilateral vocal cord.

Description

Inclusion Criteria:

  • elective polypectomy of unilateral vocal cord
  • age between 18 to 40
  • be able to communicate
  • estimated operation time less than 15min
  • ASA I-II
  • Agree to sign written informed consent

Exclusion Criteria:

  • pregnancy or breastfeeding women
  • severe gastrointestinal reflex disease
  • neuromuscular disease
  • body mass index(BMI)>30
  • predictable difficult airway.
  • allergy to medicine would be used in the present study including propofol, remifentanil or sugammadex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of laryngomicrosurgery
Time Frame: From the day before surgery till 2 days after surgery or before discharge
complete the surgery within 15min,nonintubated,remove the polyp entirely,recover completely after surgery, no major adverse event
From the day before surgery till 2 days after surgery or before discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Total days that participants stay in hospital
Time Frame: Through study completion, an average 2 days.
Through study completion, an average 2 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2020

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

January 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 11, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diansansu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vocal Polyp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe