Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE

NCT ID: NCT04247412

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vocal Polyp

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

diansan su

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Diansan su, Dr.

Role: CONTACT

+86 18616514088

Yichen Fan, M.S.

Role: CONTACT

+86 13482827569

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Diansan Su

Role: primary

+862168383702

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37076883 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

diansansu

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.