Sedation During Spinal Anesthesia
Model scores of the 29,894 trials active now.
Model score 6% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-03-07, after 2018-07-14 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 2020-03-07. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: spinalpriorsurgeryneurological disordersblock
Phrases that lowered it: effect ofcardiovascularagedmidazolam18 to -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 321 (raises risk) · Sponsor's track record
-
Blinding: quadruple (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Responsible party: principal investigator (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: 20.8% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 193 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 92.8% (raises risk) · Drug's FDA history
-
Maximum age: 50 (lowers risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 193 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 321 (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
- 16105 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2614 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ketamine, midazolam
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
- Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery NCT04971759 · started 2019 · scored riskier than 11% of active trials completed
- Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries NCT06319859 · started 2024 · scored riskier than 8% of active trials completed
- Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy NCT02462174 · started 2015 · scored riskier than 12% of active trials completed
- Post-operative Analgesic Effects of Dexamethasone Added to Bupivacaine in Transversusabdominis Plane (TAP) Block NCT03863977 · started 2019 · scored riskier than 7% of active trials completed
- Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia. NCT03976934 · started 2020 · scored riskier than 16% 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.