Recruiting
Phase 2
Phase 3

Fentanyl

Sponsor:

Loyola University

Code:

NCT02489019

Conditions

Hypotension

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Sodium chloride

Fentanyl

Study Details

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

Study ID

NCT02489019

Start date

Feb 19, 2018

Status verified date

Jun, 2019

Completion date

Dec, 2022

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control

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

experimental: Low Dose

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

experimental: High Dose

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

Interventions

Sodium chloride

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

Fentanyl

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

Primary outcome measure

  • Development of hypotension [ Time Frame: At 60 minutes following dose administration ]

Central Contacts and Locations

Central contacts

Jeffrey Hartwig, MD

708-216-1213jehartwig@lumc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Jeffrey Hartwig, MD

708-216-1213jehartwig@lumc.edu

Principal Investigator:

Jeffrey Hartwig, MD

More Information

Sponsor

Loyola University

Last update posted

Jun 5, 2019

Last verified

Jun, 2019

Keywords

  • Anesthesia
  • Fentanyl
  • Elderly

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2019-06-05.