Safety and Feasibility of Reversible Induction Strategy

• Conditions: Gastric Cancer; Colon Cancer; Prostatic Cancer; Patients With Uncertain Difficult Airway

• Registration Number: NCT04434963
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Study Start: 2021-02-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-11
• Last Update Posted: 2021-09-14
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful rate of reversion	From the beginning of induction to 15min later

Secondary Outcome Measures

Name	Time	Method
consciousness reversion time	From the beginning of induction to 15min later
Tidal volume 6-8ml tidal volume 6-8ml/kg reversion time	From the beginning of induction to 15min later
TOFr 0.9 reversion time	From the beginning of induction to 15min later
BIS 80 reversion time	From the beginning of induction to 15min later

Trial Locations

Locations (1)

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China