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Status unknownNCT04247412NIDPUpdated Sep 14, 2021

Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE

An observational study in Vocal Polyp, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-09-14.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 40 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Vocal Polyp

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Keywords

  • Laryngomicrosurgery
  • Nonintubated deep paralysis
  • Transnasal Humidified Rapid-insufflation Ventilatory Exchange
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In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 199 observational studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Success rate of laryngomicrosurgery

    complete the surgery within 15min,nonintubated,remove the polyp entirely,recover completely after surgery, no major adverse event

    Time frame: From the day before surgery till 2 days after surgery or before discharge

Secondary outcomes

  1. Total days that participants stay in hospital

    Time frame: Through study completion, an average 2 days.

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Study locations

1 of 1 sites recruiting
  • Renji Hospital
    Shanghai, Shanghai 200127, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04247412
Lead sponsor
RenJi Hospital
Responsible party
diansan su (Principal Investigator, RenJi Hospital) — Principal investigator
First posted
Jan 30, 2020
Start date
Apr 20, 2020
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Sep 14, 2021

Study contacts

Diansan su, Dr.
Contact
184872238@qq.com
+86 18616514088
Yichen Fan, M.S.
Contact
mcking95@163.com
＋86 13482827569

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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