Prospective IR-led Sedation Feasibility
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCAMC Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 and older
Planned to undergo an image-guided IR procedure for which general anesthesia would ordinarily be requested, as determined by the performing IR physician
Determined by the performing IR physician to be an appropriate candidate for attempted IR-led ketamine- based deep sedation, with anesthesiology available for escalation if needed
Ability to provide written informed consent for participation in a study involving deep sedation
Disqualifiers
Ingestion of solid food within 6-8 hours prior to the procedure, per institutional deep sedation guidelines
Known allergy or hypersensitivity to ketamine, fentanyl or midazolam
Inability to provide informed consent or lack of decision-making capacity
Prisoner status
Trial design
Design model
Single group
Treatments tested in this trial
ketamine
DrugKetamine 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.
Fentanyl (IV)
Drug25-50 mcg of intravenous fentanyl will be administered every 10-15 minutes as needed during the procedure.
Midazolam
DrugMidazolam 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Ketamine-based SedationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Aim 1 - Feasibility
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
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.Secondary outcomes
1
Patient-Reported Pain
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
Pre-procedure (baseline; immediately before procedure) and post-procedure (immediately after recovery period; within 2 hours post-op).2
Patient Satisfaction
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
Questionnaire given after recovery from procedure (within 2 hours post-op).3
Recovery Duration
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
Immediately post-procedure to discharge from recovery area (within 2 hours post-op).4
Sedation-Related Adverse Events
Sedation-related adverse events will be prospectively documented and will include: * Hypotension or hypertension requiring intervention * Oxygen desaturation \<90% * Need for airway intervention * Escalation to anesthesiology takeover and/or conversion to general anesthesia * Administration of reversal agents * Post-procedural nausea, vomiting, or hallucinations not responsive to medications 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.
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.Sponsors and contacts
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Source ClinicalTrials.gov