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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Hemodynamic Instability
• Intervention / Treatment: Device: Airtraq; Device: Macintosh

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Ⅰ-Ⅱ

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Airtraq; Patients received DLT intubation by Airtraq videolarygoscope	Device: Airtraq; Airtraq is a kind of videolaryngoscope for intubation
Active Comparator: Macintosh; Patients received DLT intubation by Macintosh laryngoscope	Device: Macintosh; Macintosh is a traditional laryngoscope for intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil TCI effect site concentration	preestablish remifentanil TCI effect site concentration(ng/ml)	through study completion, an average of 20 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Chair: Ailin Luo, M.D., alluo@tjh.tjmu.edu.cn

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 17, 2019

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 18, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: remifentanil; target controlled infusion; double-lumen tube intubation
• Other Study ID Numbers: TJMZK20180713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No