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NCT03728686 Clinical Trial

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

Intubation, Intratracheal Clinical Trial

Official title:
The Hemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03728686
Other study ID # 16MMHIS097e
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 16, 2016
Est. completion date July 30, 2018

Study information
Verified date November 2018
Source Mackay Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date July 30, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- with American Society of Anesthesiologists (ASA) physical status classification 1&2

- undergo elective surgery

- intubation

Exclusion Criteria:

- Opioids allergy history

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan MacKay Memorial Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Chien-Chung,Huang

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Derbyshire DR, Chmielewski A, Fell D, Vater M, Achola K, Smith G. Plasma catecholamine responses to tracheal intubation. Br J Anaesth. 1983 Sep;55(9):855-60. — View Citation

Martin DE, Rosenberg H, Aukburg SJ, Bartkowski RR, Edwards MW Jr, Greenhow DE, Klineberg PL. Low-dose fentanyl blunts circulatory responses to tracheal intubation. Anesth Analg. 1982 Aug;61(8):680-4. — View Citation

Parida S, Ashraf NC, Mathew JS, Mishra SK, Badhe AS. Attenuation of the haemodynamic responses to tracheal intubation with gabapentin, fentanyl and a combination of both: A randomised controlled trial. Indian J Anaesth. 2015 May;59(5):306-11. doi: 10.4103/0019-5049.156885. — View Citation

Sawano Y, Miyazaki M, Shimada H, Kadoi Y. Optimal fentanyl dosage for attenuating systemic hemodynamic changes, hormone release and cardiac output changes during the induction of anesthesia in patients with and without hypertension: a prospective, randomized, double-blinded study. J Anesth. 2013 Aug;27(4):505-11. doi: 10.1007/s00540-012-1552-x. Epub 2013 Jan 12. — View Citation

Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary heart rate heart rate 0-10 minutes during induction
Primary systolic blood pressure systolic blood pressure 0-10 minutes during induction
Primary diastolic blood pressure diastolic blood pressure 0-10 minutes during induction
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