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
Qualifiers
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
Treatments tested in this trial
- ketamine
- Fentanyl (IV)
- Midazolam
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov