Safety and Feasibility of Reversible Induction Strategy

Gastric Cancer Clinical Trial

Official title:

Safety and Feasibility of Reversible Induction Strategy Supported by HFNC Combined With Specific Anesthetic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434963
• Other study ID #: RenjiH6502
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2021
• Source: RenJi Hospital
• Contact: diansan su
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study would explore the safety and feasibility of a reversible induction strategy for uncertain difficult airway. This reversible induction strategy would include high flow nasal canular oxygenation support, short-term effect anesthetic including Propofol and Remifentanil for sedation and analgesia and Sugammadex would be used for reverse the muscle relaxant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• >18 years old,<65 years old
• Signed informed consent
• Undergoing selective operation ( time of operation is over two hours)
• ASA classification I-II
• Mallampati classification 3-4
• suspicious difficult airway, but the anesthetists decide to try to rapid induction

Exclusion Criteria:

• Patients with several dysfunctions of liver, kidney or heart)
• Patients with a full stomach or have other risk factors of reflux aspiration
• Any medicine was taken before surgery, which might enhance or mitigate the effects of muscle relaxant
• Infection of the mouth or nose
• Allergy history of any medicine which would be used in this study
• Pregnant and lactating women
• Patients with neuromuscular disease

Related Conditions & MeSH terms

• Colon Cancer
• Gastric Cancer
• Patients With Uncertain Difficult Airway
• Prostatic Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
China	Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University	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	Successful rate of reversion		From the beginning of induction to 15min later
Secondary	TOFr 0.9 reversion time		From the beginning of induction to 15min later
Secondary	BIS 80 reversion time		From the beginning of induction to 15min later
Secondary	Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time		From the beginning of induction to 15min later
Secondary	consciousness reversion time		From the beginning of induction to 15min later