Adverse effects of general anaesthetics.
M C Berthoud, C S Reilly
https://pubmed.ncbi.nlm.nih.gov/1418699/Actively Recruiting
Led by CAMC Health System · Updated on 2026-03-09
40
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether certain interventional radiology IR procedures can be safely performed using deep sedation with ketamine instead of general anesthesia. This approach aims to reduce the need for general anesthesia, which requires many staff and equipment and may cause side effects. The study is a prospective, single-center, single-arm feasibility pilot initially including 20 patients, with possible expansion to 40 if early results show safety and feasibility. Participants will receive IR-led deep sedation using a combination of ketamine, midazolam, and fentanyl during their image-guided procedures that normally require general anesthesia. The sedation involves an initial intravenous bolus of midazolam followed by ketamine doses, with additional doses of ketamine, midazolam, and fentanyl given as needed to maintain deep sedation. The anesthesiology team will be available for immediate help if necessary. Participants will be enrolled just before their procedure and monitored throughout. Researchers will assess whether the procedure completes without needing to switch to general anesthesia or stop early. They will also evaluate patient pain, satisfaction, any sedation-related side effects, and recovery time. These assessments occur during and up to two hours after the procedure, with all study activities completed in one day.
CONDITIONS
Prospective IR-led Sedation Feasibility
A
Amy R Deipolyi, M.D., Ph.D.
A
Adam M Belcher, Ph.D.
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CAMC Health System
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | IR-Led Ketamine-Based Deep Sedation | General Anesthesia (Usual Care) |
|---|---|---|
| What it is | A deep sedation protocol led by IR physicians using intravenous ketamine, combined with midazolam and fentanyl, during image-guided IR procedures. | A general anesthetic protocol delivered by anesthesia professionals to achieve complete unconsciousness for IR procedures requiring deep sedation. |
| Role in trial | Investigational sedation protocol being assessed for feasibility and safety as an alternative to general anesthesia. | Serves as the current standard method for providing deep sedation during IR procedures, outside of the trial. |
| Primary use | To provide deep sedation in adults during IR procedures without routine general anesthesia and with anesthesiology available if needed. | To induce and maintain unconsciousness and pain control for IR procedures requiring deep sedation, usually delivered by anesthesia providers. |
| How it is given or performed | Administered by IR physicians with an initial intravenous bolus of 30–50 mg ketamine, plus 1–2 mg midazolam, and 25–50 mcg fentanyl as needed; further boluses provided as required during the procedure, with anesthesiology support available for escalation. | General anesthesia induced and monitored by anesthesia professionals, often using a combination of intravenous and/or inhaled anesthetics, with airway management and continuous monitoring throughout the IR procedure. |
| Evidence status | Evidence for the IR-led ketamine sedation approach is limited to early feasibility studies and small-scale trials. Larger comparative studies are needed to determine its effectiveness and safety relative to standard anesthesia. | General anesthesia is supported by extensive published data across settings and remains the most evidence-based method for achieving reliable deep sedation and procedural pain control during IR procedures. |
| Important limitations | Feasibility and safety in broader populations remain unproven, with unknown risks in patients with certain medical conditions. Not all patients may tolerate or be eligible for IR-led deep sedation with ketamine. | General anesthesia is associated with risks of serious complications, need for airway intervention, adverse effects during recovery, and possible longer recovery times and costs compared to targeted sedation. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Same day as the procedure
Participants receive deep sedation led by the Interventional Radiology team using ketamine, midazolam, and fentanyl during their interventional radiology procedure.
1 visit (in-person)
Duration - Up to 2 hours post-procedure
Participants complete a patient satisfaction survey and recovery assessments within 2 hours after the procedure.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/18717664/CAMC Health System
Lead Sponsor