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

NCT02489019 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-06-05

No results posted yet for this study

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

Interventions

DRUG

Sodium chloride

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

DRUG

Fentanyl

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

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Jeffrey Hartwig, MD · Loyola University Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2020-07-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489019 on ClinicalTrials.gov