NCT Number: NCT07443254
This study wants to see if some interventional radiology (IR) procedures can be done without using general anesthesia. General anesthesia needs a lot of staff and equipment. It can also cause side effects. There are not enough anesthesia providers, which makes it harder to use for every procedure.
The researchers will test deep sedation with ketamine instead. They will start with 20 patients. If it works well and is safe, they may include up to 40 patients.
Patients will be asked to join the study before their procedure. The anesthesia team will be told ahead of time and will be ready to help if needed. The IR team will give the deep sedation and follow all safety rules.
The main goal is to finish the procedure without stopping early or switching to general anesthesia. The study will call this successful if fewer than 10% of cases fail. The researchers will also look at patient pain, patient satisfaction, any side effects, and how long recovery takes.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Charleston, West Virginia, 25304, United States
Location status: Recruiting
Adam M Belcher, Ph.D.
SUB_INVESTIGATOR
Amy R Deipolyi, M.D., Ph.D.
CONTACT
Amy R Deipolyi, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Michael V Korona, M.D.
SUB_INVESTIGATOR
Steven M Cooper, M.D.
SUB_INVESTIGATOR
The long-term goal of this study is to improve patient care and healthcare system efficiency by reducing reliance on general anesthesia (GA) for interventional radiology (IR) procedures that have traditionally required anesthesiology support. GA is resource-intensive, associated with airway instrumentation and postoperative side effects, and increasingly constrained by national anesthesiology workforce shortages. This prospective, single-center, single-arm feasibility pilot will evaluate IR-led ketamine-based deep sedation in an initial cohort of 20 patients undergoing IR procedures that would ordinarily be performed under GA, with prespecified expansion to up to 40 participants if early feasibility and safety criteria are met. Eligible patients will be approached prior to their procedure, and the anesthesiology service will be formally consulted in advance and available for immediate escalation if needed. Deep sedation will be administered by the IR sedation team under institutional deep sedation privileges and monitoring standards. The primary outcome is feasibility: successful completion of the planned procedure without failure, where failure is defined as procedure abortion due to inadequate sedation or intolerance, or escalation to anesthesiology takeover and/or conversion to GA. A prespecified feasibility threshold of ≤10% failure will be used. Secondary outcomes include patient-reported pain and satisfaction, peri-procedural adverse events, and recovery duration.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ketamine will be administered as follows: initial intravenous bolus of 30-50 mg intravenous ketamine, with additional 10-30 mg ketamine boluses administered every 10-15 minutes as needed, not to exceed a maximum dose of 2 mg/kg.
25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.
Midazolam will be administered as follows: an initial intravenous bolus of 1-2 mg midazolam followed by maintenance boluses of 0.5-1 mg intravenous midazolam as needed to achieve deep sedation.
Time frame: From enrollment in the study immediately before the procedure to the completion of the patient satisfaction survey given after surgical recovery, within 2-hours post-op. Enrollment, procedure, and survey are completed in the same day.
For Aim 1, feasibility will be assessed by calculating the proportion of procedures completed without failure, where failure is defined as procedure abortion due to inadequate sedation or patient intolerance, or escalation to anesthesiology takeover and/or conversion to general anesthesia. The observed failure proportion will be reported with exact (Clopper-Pearson) 95% confidence intervals. Feasibility will be interpreted relative to the prespecified threshold of ≤10% failure.
Time frame: Pre-procedure (baseline; immediately before procedure) and post-procedure (immediately after recovery period; within 2 hours post-op).
Pain will be assessed using the validated 10-point Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents worst imaginable pain. The study coordinator will document pre-procedure pain and post-procedure pain in the immediate recovery period. If a participant reports no recall of the procedure, this will be recorded as "no recall of pain/procedure" rather than imputing a numeric score. All pain scale measurements occur the same day as the procedure, and there are no other longitudinal measurements.
Time frame: Questionnaire given after recovery from procedure (within 2 hours post-op).
Patient satisfaction will be assessed using a modified Heidelberg peri-anesthetic questionnaire (18 questions) administered in the recovery area prior to discharge or return to the inpatient unit. Questions 1-16 are rated on a scale from 1 (Strongly Disagree) to 4 (Strongly Agree). Question 17 asks if the patient would, in the future, have "more sedation," "same sedation," or "less sedation." Question 18 asks the patient to rate their level of pain on a scale from 0 (no pain) to 10 (worst possible pain).
Time frame: Immediately post-procedure to discharge from recovery area (within 2 hours post-op).
Recovery duration will be defined as the time from procedure completion to discharge from the procedural recovery area or return to the inpatient unit, reflecting clinically meaningful recovery rather than anesthetic emergence alone.
Time frame: The procedure begins and finishes in one day. Adverse events that occur during the procedure, immediately after, and after recovery (within 2-hours post-procedure) will be recorded.
Sedation-related adverse events will be prospectively documented and will include:
Procedure-related adverse events will include bleeding, pneumothorax, infection, and other complications classified according to Society of Interventional Radiology (SIR) Standards of Practice. Vital signs, including lowest oxygen saturation and lowest and highest blood pressure during the procedure, will be recorded. This outcome is for the single day in which the procedure occurs. No pre-procedural or longitudinal data is applicable.
Contact information is provided by the study sponsor or research team.
Adam M Belcher, Ph.D.
CONTACT
Amy R Deipolyi, M.D., Ph.D.
CONTACT
CAMC Health System
Other
Prospective Single-Arm Feasibility Study of IR-led Deep Sedation for Interventional Radiology Procedures Traditionally Performed With Anesthesiology Support
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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