Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE
NIDP
Laryngomicrosurgery Under Nonintubated Deep Paralysis (NIDP) General Anesthesia Supported by Transnasal Humidified Rapid-insufflation Ventilatory Exchange: A Case Series Study
1 other identifier
observational
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedStudy Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 14, 2021
September 1, 2021
1.6 years
January 27, 2020
September 11, 2021
Conditions
Keywords
Outcome Measures
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
From the day before surgery till 2 days after surgery or before discharge
Secondary Outcomes (1)
Total days that participants stay in hospital
Through study completion, an average 2 days.
Eligibility Criteria
Young patients who will under elective polypectomy of unilateral vocal cord.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
Fan Y, Chi X, Zhu D, Yin J, Liu Y, Su D. Non-intubated deep paralysis: a new anaesthesia strategy for vocal cord polypectomy. Perioper Med (Lond). 2023 Apr 19;12(1):12. doi: 10.1186/s13741-023-00301-7.
PMID: 37076883DERIVED
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 27, 2020
First Posted
January 30, 2020
Study Start
April 20, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09