Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients

NCT06165679 on ClinicalTrials.gov Phase 3 Cairo University (academic or other) Started 2023-12-20 Completed

Riskier than 7% of active trials

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2025-06-30, after 2023-12-20 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-06-30. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Sponsor's past termination rate: 0.5% (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: dosescontrolledpatientdisordersinfections
Phrases that lowered it: patientsbleedingclasshypertensiveanesthesia
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 833 (raises risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Drug's FAERS reports with a death: 9.1% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 65 (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports marked serious: 71.6% (lowers risk) · Drug's FDA history
Sponsor's past trials: 983 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports before start: 55125 (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 65 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 983 (typical: 32)
Sponsor's past termination rate: 0.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 833 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 55125 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5128 (typical: 412.5)
Drug's FAERS reports marked serious: 71.6% (typical: 85.6%)
Drug's FAERS reports with a death: 9.1% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: bupivacaine, prilocaine

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries. NCT05726968 · started 2022 · scored riskier than 6% of active trials completed
Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics NCT06382220 · started 2024 · scored riskier than 10% of active trials completed
Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations. NCT03260283 · started 2017 · scored riskier than 13% of active trials completed
To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP NCT05285800 · started 2021 · scored riskier than 6% of active trials completed
Preoperative Oral Pregabalin Effect on Inhalational Anesthetic Requirements ln Hysterectomy Under General Anesthesia NCT03302208 · started 2017 · scored riskier than 9% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.