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NCT07914868
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Conditions: Spinal Anaesthesia Induced Hypotension
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 142
Sponsor: Assiut University
Location: Assiut University Asyut
Summary
This study aims to compare prophylactic intravenous ondansetron 4 mg versus placebo regarding the incidence of spinal anaesthesia-induced hypotension, defined as mean arterial pressure (MAP) fall \>20% from baseline or systolic blood pressure (SBP) \20% from baseline, in elderly patients undergoing fracture hip surgery. The hypothesis is that a significant difference exists.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 65 years
* American Society of Anesthesiologists (ASA) physical status I, II, III (according to the American Society of Anesthesiologists classification).
* Scheduled for elective hip fracture surgery under spinal anaesthesia.
Exclusion Criteria:
* Patient refusal or inability to provide informed consent.
* Contraindication to spinal/neuraxial anaesthesia (coagulopathy, local infection at injection site, patient refusal, severe spinal deformity).
* Known hypersensitivity or contraindication to ondansetron (e.g., congenital long-QT syndrome).
* Baseline cardiac arrhythmia, significant conduction abnormality, or QTc \> 450-470 ms on preoperative ECG.
* Severe cardiovascular disease (decompensated heart failure, recent myocardial infarction, severe valvular disease), ASA IV-V.
* Baseline bradycardia (heart rate \< 50 bpm) or use of a permanent pacemaker.
* Concurrent use of medications that significantly affect heart rate or QT interval (e.g., class III antiarrhythmics), or of another 5-HT3 antagonist within 24 hours.
* Emergency surgery, or planned combined spinal-general anaesthesia/conversion anticipated.
* Pregnancy (not applicable in most cases given the population) and cognitive impairment precluding valid consent or symptom reporting.
Source: ClinicalTrials.gov (NCT07914868). StuddyBuddy aggregates publicly available trial information.