Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Response to Endotracheal Tube Intubation at Different Time of Fentanyl Given During Induction

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: NCT03728686
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Chien-Chung,Huang, Mackay Memorial Hospital

Brief Summary:
Opioids have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine. Patients'details will be recorded too.

Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Other: Different given time Not Applicable

Detailed Description:

Laryngoscopy and intubation often provoke hypertension and tachycardia due to the stimulation both sympathetic and sympathoadrenal activities. While the adverse hemodynamic effects of laryngoscopy and endotracheal intubation can precipitate myocardial ischemia, even in patients without hypertension, the responses are exaggerated in patients with hypertension . In the previous studies , many drugs, including opioids and beta-blockers, have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine.

All patients were premedicated with Midazolam 0.1mg/kg , Lidocaine 0.5mg/kg (L), Propofol 2mg/kg (P), Rocuronium 1mg/kg (R) before induction of general anesthesia. Laryngoscopy lasting a maximum of 30 s was attempted 3 min after administration of the induction agents. Fentanyl 2mcg/kg was given at different time before intubation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Hemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: a Randomized Controlled Trial
Actual Study Start Date : December 16, 2016
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl

Arm Intervention/treatment
Experimental: 3mins
Different given time: Fentanyl 2mcg/kg was given at either time 3 minutes before intubation
Other: Different given time
Fentanyl 2mcg/kg (F) was given at either 1,2,3 minutes before intubation

Active Comparator: 2mins
Different given time: Fentanyl 2mcg/kg was given at either time 2 minutes before intubation
Other: Different given time
Fentanyl 2mcg/kg (F) was given at either 1,2,3 minutes before intubation

No Intervention: control
Different given time: Fentanyl 2mcg/kg was given at either time 1 minute before intubation



Primary Outcome Measures :
  1. heart rate [ Time Frame: 0-10 minutes during induction ]
    heart rate

  2. systolic blood pressure [ Time Frame: 0-10 minutes during induction ]
    systolic blood pressure

  3. diastolic blood pressure [ Time Frame: 0-10 minutes during induction ]
    diastolic blood pressure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • with American Society of Anesthesiologists (ASA) physical status classification 1&2
  • undergo elective surgery
  • intubation

Exclusion Criteria:

  • Opioids allergy history

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): NCT03728686


Locations
Layout table for location information
Taiwan
MacKay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Chien-Chung,Huang
Investigators
Layout table for investigator information
Study Director: Chicn-Chung Huang, MD Mackay Memorial Hospital
Publications:
Layout table for additonal information
Responsible Party: Chien-Chung,Huang, attending physician, department of anesthesiology, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03728686    
Other Study ID Numbers: 16MMHIS097e
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chien-Chung,Huang, Mackay Memorial Hospital:
Intubation, Intratracheal