HypotensionPhase 2/3FentanylNCT02489019
Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia
A Phase 2/3 study testing Sodium chloride and Fentanyl in people with Hypotension, run by Loyola University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Sodium chloride and Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Jeffrey Hartwig, MD, 708-216-1213, jehartwig@lumc.edu
Jeffrey Hartwig, MD
About this study
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.
Read the 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.
- Conditions
- Hypotension
- Being tested
- Sodium chloride, Fentanyl
- Keywords
- Anesthesia, Fentanyl, Elderly
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chlorideDrug
Also called NaCL
Sodium chloride will be used as a placebo comparator in this trial
FentanylDrug
Also called Actiq, Duragesic, Fentora, Sublimaze
Fentanyl is a synthetic opioid analgesic that will be used as the experimental intervention in this trial
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Individuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL) Receives: Drug: Sodium chloride |
| Low Dose | Experimental | Individuals assigned to this condition will receive 1 mcg/kg fentanyl Receives: Drug: Fentanyl |
| High Dose | Experimental | Individuals assigned to this condition will receive 2 mcg/kg fentanyl Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of hypotension
Blood pressure will be recorded 60 minutes after administration of the study agent
Measured: At 60 minutes following dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start19 Feb 2018
- Primary completionJul 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Hartwig, Loyola University
- Investigators
- Jeffrey Hartwig, MD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489019
- Sponsor's protocol ID
- 204821
- Acronym
- Fentanyl
- Status last verified
- Jun 2019
- First submitted
- 1 Jul 2015
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19934864Bijker 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.
PubMed 17667564Billard 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.
PubMed 7992907Reich 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.
PubMed 16115962Monk 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.
PubMed 15616043
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT02489019
- Acronym / sponsor ID
- Fentanyl / 204821
- Conditions
- Hypotension
- Keywords
- Anesthesia, Fentanyl, Elderly
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Sodium chlorideIndividuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL) |
| Low Dose | Experimental | Drug: FentanylIndividuals assigned to this condition will receive 1 mcg/kg fentanyl |
| High Dose | Experimental | Drug: FentanylIndividuals assigned to this condition will receive 2 mcg/kg fentanyl |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chlorideAlso: NaCLSodium chloride will be used as a placebo comparator in this trial | Drug | Control |
| FentanylAlso: Actiq, Duragesic, Fentora, SublimazeFentanyl is a synthetic opioid analgesic that will be used as the experimental intervention in this trial | Drug | High Dose, Low Dose |
Primary outcome
Development of hypotension
Time frame: At 60 minutes following dose administration
Blood pressure will be recorded 60 minutes after administration of the study agent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Background: PubMed 19934864Bijker 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.
- Background: PubMed 17667564Bijker 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.
- Background: PubMed 7992907Billard 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.
- Background: PubMed 16115962Reich 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.
- Background: PubMed 15616043Monk 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.
- Individual participant dataSharing planned: No
Related trials for Hypotension
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Hartwig, MD principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium chloride and Fentanyl in people with Hypotension, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Hartwig, MD (708-216-1213, jehartwig@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of hypotension (time frame: At 60 minutes following dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02489019, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.