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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653910
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Wenlong Yao, Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Hemodynamic Instability Intubation Complication Device: Airtraq Device: Macintosh Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 17, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Remifentanil TCI effect site concentration [ Time Frame: through study completion, an average of 20 min ]
    preestablish remifentanil TCI effect site concentration(ng/ml)


Secondary Outcome Measures :
  1. mean arterial pressure [ Time Frame: 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 ]
    mean arterial pressure in mmHg

  2. heart rate [ Time Frame: 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 in bpm

  3. Narcotrend index [ Time Frame: 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 in Arabic numerals



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653910


Locations
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China, Hubei
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Chair: Ailin Luo, M.D. alluo@tjh.tjmu.edu.cn

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Responsible Party: Wenlong Yao, M.D,PhD, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03653910    
Other Study ID Numbers: TJMZK20180713
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wenlong Yao, Huazhong University of Science and Technology:
double-lumen tube intubation
remifentanil
target controlled infusion
Additional relevant MeSH terms:
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Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents