Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia

NCT02489019 | Unknown Phase 2 FDA Drug

• 1 other identifier: 204821
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotension is frequently encountered after induction of general anesthesia. It can be pronounced in elderly patients and can require administration of vasopressor agents including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged episodes, can contribute to an increase in morbidity and mortality in the postoperative period as suggested by some former studies. The investigators hypothesize that fentanyl can contribute to the decrease in blood pressure (BP) that is seen after induction of general anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the sympathetic nervous system. This study will be the first one to examine the effect of fentanyl administration on blood pressure in elderly patients with induction of general anesthesia prior to the start of surgery. If the study shows that fentanyl contributes to hypotension during this period, it may lead to a change in practice and better patient outcomes and mortality rates.

Conditions

Hypotension

Keywords

Anesthesia; Fentanyl; Elderly

Outcome Measures

Primary Outcomes (1)

• Development of hypotension

  Blood pressure will be recorded 60 minutes after administration of the study agent

  At 60 minutes following dose administration

Study Arms (3)

Control

PLACEBO COMPARATOR

Individuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL)

Drug: Sodium chloride

Low Dose

EXPERIMENTAL

Individuals assigned to this condition will receive 1 mcg/kg fentanyl

Drug: Fentanyl

High Dose

EXPERIMENTAL

Individuals assigned to this condition will receive 2 mcg/kg fentanyl

Drug: Fentanyl

Interventions

Sodium chloride DRUG

Sodium chloride will be used as a placebo comparator in this trial

Also known as: NaCL

Control

Fentanyl DRUG

Fentanyl is a synthetic opioid analgesic that will be used as the experimental intervention in this trial

Also known as: Actiq, Duragesic, Fentora, Sublimaze

High Dose; Low Dose

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 60 years and older
• Patients coming from home (including those who will be admitted post-operatively)
• Surgeries with general anesthesia alone or if combined with peripheral nerve blocks
• Patients must be seen at the Russo operating room at Loyola Medical Center (Maywood, IL)

You may not qualify if:

• Age less than 60
• Patient refusal
• Inpatient or emergency cases
• Patients having combined general anesthesia and epidural anesthesia
• Patients with a pre-induction mean arterial blood pressure (MAP) less than 50 or greater than 150
• Patients who will receive rapid sequence induction with succinylcholine
• Patients scheduled for cardiovascular surgery
• Patients scheduled for inhalational induction
• Patients with weight greater than 125 kg
• Patients with a history of chronic opioid use

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (5)

• Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.

  PMID: 19934864 BACKGROUND

• Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.

  PMID: 17667564 BACKGROUND

• Billard V, Moulla F, Bourgain JL, Megnigbeto A, Stanski DR. Hemodynamic response to induction and intubation. Propofol/fentanyl interaction. Anesthesiology. 1994 Dec;81(6):1384-93. doi: 10.1097/00000542-199412000-00013.

  PMID: 7992907 BACKGROUND

• Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.

  PMID: 16115962 BACKGROUND

• Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

  PMID: 15616043 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Sodium Chloride; Fentanyl

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey Hartwig, MD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Hartwig, MD

CONTACT

708-216-1213; jehartwig@lumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 2, 2015
• Study Start: February 19, 2018
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2022
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)