Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope

Hemodynamic Instability Clinical Trial

Official title:

Effect-site Concentration of Remifentanil for Inhibiting Cardiovascular Responses to Double-lumen Tube Intubation With Airtraq Videolaryngoscopy: a Comparative Study With Macintosh Laryngoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653910
• Other study ID #: TJMZK20180713
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: May 2019
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The 50% effective concentration of remifentanil by target controlled infusion was not determined for inhibiting the haemodynamic response during double-lumen tube (DLT) intubation. Previous study showed that Airtraq videolaryngoscope provided more stable haemodynamics than Macintosh for double-lumen tube intubation. In this study, the investigators will compare the 50% effective concentration of remifentanil between Airtraq videolaryngoscope and Macintosh laryngoscope for inhibiting haemodynamic responses during DLT intubation.

Description:

Dixon "up-and-down" method was used to determine 50% effective concentration of remifentanil by target controlled infusion for inhibiting the haemodynamic responses during DLT intubation with Airtraq videolaryngoscope or Macintosh laryngoscope.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 17, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criterias:

1. American Society of Anesthesiologists physical status of I-II

2. Patients aged 18-65 years

3. BMI 18-35 kg/m2

4. Elective pulmonary surgery under general anesthesia to double-lumen tubes intubation

5. Mallampati classifications ?-?

Exclusion Criterias:

1. Emergency operation

2. Anticipated difficult airway or history of intubation difficulties

3. Be allergic to any of the drugs used in the experiment, or have a history of drug allergy

4. Preoperative use of analgesic, sedative and other drugs

5. Uncontrolled hypertension and heart disease

6. Have a history of heavy smoking and alcohol abuse, serious drug abuse, and severe systemic infections

7. There are severe mental and nervous system symptoms, and patients cannot cooperate with the study, such as language comprehension disorder, mental illness, etc

8. Other clinical trials were conducted within 3 months prior to inclusion in the study

Related Conditions & MeSH terms

• Hemodynamic Instability
• Intubation Complication

Intervention

Device:
• Airtraq
Airtraq is a kind of videolaryngoscope for intubation
• Macintosh
Macintosh is a traditional laryngoscope for intubation

Locations

Country	Name	City	State
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remifentanil TCI effect site concentration	preestablish remifentanil TCI effect site concentration(ng/ml)	through study completion, an average of 20 min
Secondary	mean arterial pressure	mean arterial pressure in mmHg	at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
Secondary	heart rate	heart rate in bpm	at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation
Secondary	Narcotrend index	Narcotrend index in Arabic numerals	at entering the operation room(T1), at immediately before DLT intubation(T2), at immediately after DLT intubtion(T3), at 1 minute(T4)/2 minutes (T5)/3 minutes(T6) after DLT intubation