Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE

Vocal Polyp Clinical Trial

— NIDP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247412
• Other study ID #: diansansu
• Status: Recruiting
• Start date: April 20, 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: RenJi Hospital
• Contact: Diansan su, Dr.
• Phone: +86 18616514088
• Email: 184872238[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Vocal Polyp

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of laryngomicrosurgery	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	Total days that participants stay in hospital		Through study completion, an average 2 days.