Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 19, 2018 |
| End Date: | December 2022 |
| Contact: | Jeffrey Hartwig, MD |
| Email: | jehartwig@lumc.edu |
| Phone: | 708-216-1213 |
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.
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.
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.
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.
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
We found this trial at
1
site
2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Jeffrey Hartwig, MD
Phone: 708-216-1213
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