Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways

Summary

To compare the difference in endotracheal intubation in participants with difficult airway between under general anesthesia by Transnasal Humidified Rapid-Insufflation Ventilatory Exchange and under traditional sedation by mask ventilation. The investigators focus on the different outcomes in oxygenation maintaince, carbon dioxide removal and the effectiveness of safety apnea time, to evaluate the safety of receiving endotracheal intubation under general anesthesia in participants with difficult airway.

Conditions

• Sedative, Hypnotic, or Anxiolytic Withdrawal
• Airway Control

Interventions

DEVICE

Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.

The nasal cavity was disinfected with Iodophor cotton swab, and the appropriate nasal cavity was selected for endotracheal intubation assisted by fiberoptic bronchoscope according to the experience of anesthesiologists. After the endotracheal intubation was fixed, the anesthesia machine was connected for mechanical ventilation. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg.

DEVICE

Mask ventilation

The Control Group will receive sequential intravenous infusion of Sufentanil 5ug, midazolam 0.05mg/kg, and propofol 1-2ug/ml, to make the BIS between 70 and 80. 2ml tetracaine was injected with cyclothyroid membrane puncture, and the nasal cavity was disinfected with iodophor cotton swab. According to the experience of anesthesiologists, the appropriate nasal cavity was selected for intranasal endotracheal intubation assisted by fiberbronchoscope. After the endotracheal intubation was successful, the anesthesia machine was connected for mechanical ventilation, full narcotic inducer will be injected. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg.

DRUG

Midazolam(T group)

Midazolam 0.05mg/kg, intravenous injection

DRUG

Sufentani(T group)

Sufentanil 0.02-0.05ug/kg, intravenous injection

DRUG

Propofol(T group)

Propofol 2-3ug/ml, intravenous injection

DRUG

Rocuronium(T group)

Rocuronium 0.06mg/kg, intravenous injection

DRUG

Drug use target(T group)

Make BIS \< 60 .

DRUG

Sufentanil(C group)

Sufentanil 5ug, intravenous injection

DRUG

Midazolam(C group)

Midazolam 0.05mg/kg, intravenous injection

DRUG

Propofol

Propofol 1-2ug/ml, intravenous injection

DRUG

Tetracaine(C group)

2ml tetracaine was injected with cyclothyroid membrane puncture.

DRUG

Drug use target

Make the BIS between 70 and 80.

Sponsors & Collaborators

• Peking University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-10

Primary Completion

2022-05-10

Completion

2022-06-10

Countries

• China

Study Locations