Clinical trial NCT03653910: Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Intubation Complication
Keywords: double-lumen tube intubation
remifentanil
target controlled infusion
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Remifentanil TCI effect site concentration
timeFrame: through study completion, an average of 20 min
Secondary outcomes:
measure: mean arterial pressure
timeFrame: 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
measure: heart rate
timeFrame: 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
measure: Narcotrend index
timeFrame: 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
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: alluo@tjh.tjmu.edu.cn
name: Ailin Luo, M.D.
role: STUDY_CHAIR
References: