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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type DRUG

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

Low Dose

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

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

High Dose

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

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

Interventions

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Sodium chloride

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Other Intervention Names

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NaCL Actiq Duragesic Fentora Sublimaze

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No