Frailty and Spinal Anesthesia-Induced Hypotension in Elderly
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSelcuk University
About this trial
60 patients aged 65 and older with ASA I-III physical status undergoing elective surgery under spinal anesthesia will be included in the study.
Patients with cardiac arrhythmia, severe heart failure, cerebrovascular disease, or contraindications to neuraxial anesthesia will be excluded. Frailty assessments will be performed using the Clinical Frailty Scale (CFS) version 2.0 by anesthesiologists in preoperative clinics or wards. Participants will be categorized into frail (CFS Level ≥4, Group I) and non-frail (CFS Level ≤3, Group II) groups.
Prior to spinal anesthesia, 8 mL/kg of crystalloids will be administered. Baseline preoperative mean arterial blood pressure (MABP) and heart rate (HR) will be recorded as the average of three measurements in the supine position.
During the study, MABP and HR will be monitored every 2 minutes for the first 20 minutes post-spinal anesthesia, then every 5 minutes until surgery ends. Hypotension (MABP \<80% of baseline) will be treated with 5 mg intravenous ephedrine, while bradycardia (HR \<50 beats/min) will be treated with 0.5 mg intravenous atropine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
65 and older
ASA I-III physical status
Undergoing elective surgery under spinal anesthesia
Disqualifiers
Patients with cardiac arrhythmia
Patients with severe heart failure
Patients with cerebrovascular disease
Contraindications to neuraxial anesthesia
Trial population
Male and female patients aged 65 and over
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Frail
Group B: Non-frail
Trial outcomes
Primary outcomes
1
Rate of Hypotension
Hypotension, defined as MABP below 80% of baseline values
Time frame
Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.Secondary outcomes
1
Rate of Bradycardia
Bradycardia defined as HR \<50 beats/min
Time frame
Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.2
Ephedrine usage
Necessary use of ephedrine (mg) for patients who develop hypotension
Time frame
During the procedure3
Rate of Nausea and vomiting
Nausea and vomiting Visual analogue scale
Time frame
up to 24 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: