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

June 4, 2019 updated by: Jeffrey Hartwig, Loyola University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective double-blinded randomized controlled trial (RCT) where patients will be assigned randomly by the investigational pharmacist. Patients will be assigned to one of three groups: (1) A control group that receives 0.9 mcg/kg sodium chloride (NaCL), (2) a fentanyl group that receives 1 mcg/kg fentanyl, or (3) a fentanyl group that receives 2 mcg/kg fentanyl.

The definition of intraoperative hypotension in this study is defined as a mean blood pressure (MAP) less than 25% compared to the baseline value (i.e., the participants' first blood pressure reading after entering the operating room). All study drug agents will be dispensed by the pharmacy in five milliliter syringes labeled as "study medication". The volume of any of the three study medication will be adjusted by the pharmacist to reflect an equal volume.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey Hartwig, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Individuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL)
Drug: Sodium chloride
Sodium chloride will be used as a placebo comparator in this trial
Other Names:
  • NaCL
Experimental: Low Dose
Individuals assigned to this condition will receive 1 mcg/kg fentanyl
Drug: Fentanyl
Fentanyl is a synthetic opioid analgesic that will be used as the experimental intervention in this trial
Other Names:
  • Sublimaze
  • Actiq
  • Fentora
  • Duragesic
Experimental: High Dose
Individuals assigned to this condition will receive 2 mcg/kg fentanyl
Drug: Fentanyl
Fentanyl is a synthetic opioid analgesic that will be used as the experimental intervention in this trial
Other Names:
  • Sublimaze
  • Actiq
  • Fentora
  • Duragesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of hypotension
Time Frame: At 60 minutes following dose administration
Blood pressure will be recorded 60 minutes after administration of the study agent
At 60 minutes following dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Jeffrey Hartwig, MD, Loyola University Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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