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

Primary Purpose

Hypotension

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium chloride
Fentanyl
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Anesthesia, Fentanyl, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control

Low Dose

High Dose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2015
Last Updated
June 4, 2019
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT02489019
Brief Title
Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia
Acronym
Fentanyl
Official Title
Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Anesthesia, Fentanyl, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Individuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL)
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Individuals assigned to this condition will receive 1 mcg/kg fentanyl
Arm Title
High Dose
Arm Type
Experimental
Arm Description
Individuals assigned to this condition will receive 2 mcg/kg fentanyl
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Other Intervention Name(s)
NaCL
Intervention Description
Sodium chloride will be used as a placebo comparator in this trial
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Actiq, Duragesic, Fentora, Sublimaze
Intervention Description
Fentanyl is a synthetic opioid analgesic that will be used as the experimental intervention in this trial
Primary Outcome Measure Information:
Title
Development of hypotension
Description
Blood pressure will be recorded 60 minutes after administration of the study agent
Time Frame
At 60 minutes following dose administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Hartwig, MD
Phone
708-216-1213
Email
jehartwig@lumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Hartwig, MD
Organizational Affiliation
Loyola University Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Hartwig, MD
Phone
708-216-1213
Email
jehartwig@lumc.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Hartwig, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19934864
Citation
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.
Results Reference
background
PubMed Identifier
17667564
Citation
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.
Results Reference
background
PubMed Identifier
7992907
Citation
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.
Results Reference
background
PubMed Identifier
16115962
Citation
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.
Results Reference
background
PubMed Identifier
15616043
Citation
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.
Results Reference
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Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia

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