Digital Sedation: Virtual Reality Hypnosis During Colonoscopy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colonoscopy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua...
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures. Participants will be recruited during the anesthesiology consultation conducted in preparation for colonoscopy. Those with indication for screening or diagnostic colonoscopy under conventional intravenous sedation (propofol) and willing to participate will provide their written informed consent and will be randomized (2:1) between two arms: Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if needed upon patient request Control arm: conventional intravenous sedation (propofol) The study will be divided into two stages, with randomization (2:1) maintained throughout. In the first stage, accrual will be halted when about 45 patients have been randomized, at least 27 of whom being evaluable patients randomized to the experimental arm. A non-binding futility analysis is planned for the primary outcome. If the milestones are met, accrual will be reopened to the second stage and the study will continue to the planned final accrual of 177 patients (118 to experimental and 59 to control arm, respectively). At the end of the recruitment of Stage 1, an analysis of the secondary outcomes will also be run. Results of these analysis could also impact the decision for pursuing to second stage.
Tracking Information
- NCT #
- NCT04465383
- Collaborators
- Erasme University Hospital
- Investigators
- Principal Investigator: Daniel Blero, Prof. MD. Hôpital Erasme