Clinical trial NCT04465383: Digital Sedation: Virtual Reality Hypnosis During Colonoscopy
Official title: A Prospective Randomized Controlled Monocentric Study Comparing Digital Sedation Versus Intravenous Sedation Among Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colonoscopy
Lead sponsor: Oncomfort
Sponsor class: INDUSTRY
Collaborators: name: Erasme University Hospital
First posted: 2020-07-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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© 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:

1. Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if needed upon patient request
2. Control arm: conventional intravenous sedation (propofol)

The study will be divided into three 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. In the second stage, accrual will be halted when about 90 patients have been randomized. 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 and 2, an analysis of the secondary outcomes will also be run. Results of these analysis could also impact the decision for pursuing to second/ third stage.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)
* Provision of written informed consent

Exclusion Criteria:

* Scheduled dilation
* Active Crohn Disease
* Low auditory acuity that precludes use of the device
* Low visual acuity that precludes use of the device
* Head or face wounds precluding use of the device
* Schizophrenia
* Dizziness
* Water/sea phobia
* Non-proficiency in French or Dutch (research language)

Primary outcomes:
measure: To confirm the feasibility of using digital sedation in colonoscopy (stage 1)
timeFrame: Day 1
measure: To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)
timeFrame: Day 1
Secondary outcomes:
measure: To compare patient experience in both arms
timeFrame: Day 1 & Day 2 Follow-up call
measure: To compare measures of colonoscopy performance in both arms
timeFrame: Day 1
measure: To assess the need for rescue sedation in the experimental arm
timeFrame: Day 1
measure: To compare use of sedation medication in both arms
timeFrame: Day 1
measure: To assess gastroenterologist and anesthesiologist satisfaction in both arms
timeFrame: Day 1
measure: To assess gastroenterologist and anesthesiologist stress in both arms
timeFrame: Day 1
measure: To compare physiologic measures in both arms
timeFrame: Day 1
measure: To assess difficulty or ease of the procedure in both arms
timeFrame: Day 1
measure: To compare the safety in both arms
timeFrame: Screening, Day 1 & Day 2 Follow-up call
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme
Study officials:
affiliation: Hôpital Erasme
name: Daniel Blero, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
References: