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

NCT ID: NCT03728686

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-16
• Study Completion Date: 2018-07-30

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.

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.

Conditions

Intubation, Intratracheal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

3mins

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

Group Type: EXPERIMENTAL

Different given time

Intervention Type: OTHER

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

2mins

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

Group Type: ACTIVE_COMPARATOR

Different given time

Intervention Type: OTHER

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

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Different given time

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Opioids allergy history

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chien-Chung,Huang

OTHER

Sponsor Role: lead

Responsible Party

Chien-Chung,Huang

attending physician, department of anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chicn-Chung Huang, MD

Role: STUDY_DIRECTOR

Mackay Memorial Hospital

Locations

MacKay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 26019356 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23314694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6615672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3828177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7201271 (View on PubMed)

Other Identifiers

16MMHIS097e

Identifier Type: -

Identifier Source: org_study_id