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

NCT03653910 | Completed DMC

• 1 other identifier: TJMZK20180713
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodynamic Instability; Intubation Complication

Keywords

double-lumen tube intubation; remifentanil; target controlled infusion

Outcome Measures

Primary Outcomes (1)

• Remifentanil TCI effect site concentration

  preestablish remifentanil TCI effect site concentration(ng/ml)

  through study completion, an average of 20 min

Secondary Outcomes (3)

• mean arterial pressure

  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

  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

  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

Study Arms (2)

Airtraq

EXPERIMENTAL

Patients received DLT intubation by Airtraq videolarygoscope

Device: Airtraq

Macintosh

ACTIVE COMPARATOR

Patients received DLT intubation by Macintosh laryngoscope

Device: Macintosh

Interventions

Airtraq DEVICE

Airtraq is a kind of videolaryngoscope for intubation

Airtraq

Macintosh DEVICE

Macintosh is a traditional laryngoscope for intubation

Macintosh

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status of I-II
• Patients aged 18-65 years
• BMI 18-35 kg/m2
• Elective pulmonary surgery under general anesthesia to double-lumen tubes intubation
• Mallampati classifications Ⅰ-Ⅱ

You may not qualify if:

• Emergency operation
• Anticipated difficult airway or history of intubation difficulties
• Be allergic to any of the drugs used in the experiment, or have a history of drug allergy
• Preoperative use of analgesic, sedative and other drugs
• Uncontrolled hypertension and heart disease
• Have a history of heavy smoking and alcohol abuse, serious drug abuse, and severe systemic infections
• There are severe mental and nervous system symptoms, and patients cannot cooperate with the study, such as language comprehension disorder, mental illness, etc

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

• Ailin Luo, M.D.

  alluo@tjh.tjmu.edu.cn

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D,PhD

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 31, 2018
• Study Start: September 3, 2018
• Primary Completion: May 10, 2019
• Study Completion: May 17, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)