NCT03728686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

October 31, 2018

Last Update Submit

November 4, 2018

Conditions

Intubation, Intratracheal

Keywords

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (3)

  • heart rate

    heart rate

    0-10 minutes during induction

  • systolic blood pressure

    systolic blood pressure

    0-10 minutes during induction

  • diastolic blood pressure

    diastolic blood pressure

    0-10 minutes during induction

Study Arms (3)

3mins

EXPERIMENTAL

Different given time: Fentanyl 2mcg/kg was given at either time 3 minutes before intubation

Other: Different given time

2mins

ACTIVE COMPARATOR

Different given time: Fentanyl 2mcg/kg was given at either time 2 minutes before intubation

Other: Different given time

control

NO INTERVENTION

Different given time: Fentanyl 2mcg/kg was given at either time 1 minute before intubation

Interventions

Different given timeOTHER

Fentanyl 2mcg/kg (F) was given at either 1,2,3 minutes before intubation

2mins3mins

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Opioids allergy history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacKay Memorial Hospital

Taipei, 104, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 26019356BACKGROUND

  • 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.

    PMID: 23314694BACKGROUND

  • 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. doi: 10.1093/bja/55.9.855.

    PMID: 6615672BACKGROUND

  • 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. doi: 10.1093/bja/59.3.295.

    PMID: 3828177BACKGROUND

  • 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.

    PMID: 7201271BACKGROUND

Study Officials

  • Chicn-Chung Huang, MD

    Mackay Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
attending physician, department of anesthesiology

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 2, 2018

Study Start

December 16, 2016

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)