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

Phase 2

• Conditions: Hypotension
• Interventions: Drug: Sodium chloride; Drug: Fentanyl

• Registration Number: NCT02489019
• Lead Sponsor: Loyola University

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.

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Study Start: 2018-02-19
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05
• Primary Completion: 2020-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sodium chloride	Individuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL)
Low Dose	Fentanyl	Individuals assigned to this condition will receive 1 mcg/kg fentanyl
High Dose	Fentanyl	Individuals assigned to this condition will receive 2 mcg/kg fentanyl

Primary Outcome Measures

Name	Time	Method
Development of hypotension	At 60 minutes following dose administration	Blood pressure will be recorded 60 minutes after administration of the study agent

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States