Trial · NCT07885059
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient satisfaction | At completion of post-procedural recovery on the day of colonoscopy. | Patient satisfaction was assessed using a study-specific four-item questionnaire. Two items assessed satisfaction with the colonoscopy procedure and satisfaction with analgosedation using separate 11-point numerical rating scales ranging from 0 (completely dissatisfied) to 10 (extremely satisfied). Two additional binary items assessed whether the participant would recommend the same approach to relatives or friends and whether the participant would agree to undergo colonoscopy using the same approach again. |
| Primary | Incidence of clinically relevant respiratory adverse events | From administration of sedation through completion of monitored post-procedural recovery on the day of colonoscopy. | Incidence of protocol-defined respiratory adverse events, reported by event type. Respiratory events included apnea lasting more than 30 seconds, oxygen saturation below 90%, respiratory rate below 10 or above 20 breaths per minute, end-tidal CO2 below 35 mmHg, and the need for airway-opening interventions. Apnea lasting more than 30 seconds was analyzed as the principal respiratory safety endpoint. |
| Secondary | Total propofol dose | From initial propofol administration until completion of the colonoscopy. | Total cumulative dose of propofol administered during the colonoscopy, expressed in milligrams. |
| Secondary | Number of additional propofol boluses | From initial propofol administration until completion of the colonoscopy. | Number of additional propofol boluses administered after the initial protocol-defined propofol dose. |
| Secondary | Cumulative additional propofol dose | From initial propofol administration until completion of the colonoscopy. | Total cumulative dose of additional propofol administered after the initial protocol-defined propofol dose, expressed in milligrams. |
| Secondary | Early recovery time | From completion of colonoscopy through the early post-procedural recovery period on the day of the procedure. | Time from completion of the colonoscopy until achievement of the predefined early post-anaesthesia recovery criterion based on the Modified Aldrete Score. |
| Secondary | Total recovery time | From completion of colonoscopy until completion of monitored post-procedural recovery on the day of the procedure. | Time from completion of the colonoscopy until achievement of predefined discharge-readiness criteria based on post-anaesthesia recovery assessment, including the Post-Anesthesia Discharge Scoring System (PADSS). |
| Secondary | Cecal intubation rate | During colonoscopy. | Proportion of colonoscopies in which the colonoscope was successfully advanced to the cecum. |
| Secondary | Cecal intubation time | During the index colonoscopy. | Time from insertion of the colonoscope until successful intubation of the cecum. |
| Secondary | Colonoscope withdrawal time | During colonoscopy. | Time from initiation of colonoscope withdrawal from the cecum until completion of the examination. |
| Secondary | Adenoma detection rate | During the index colonoscopy, with histopathological confirmation following the procedure. | Proportion of participants in whom at least one colorectal adenoma was detected during the index colonoscopy and confirmed by histopathological examination. |
| Secondary | Colorectal cancer detection rate | During the index colonoscopy, with histopathological confirmation following the procedure. | Proportion of participants in whom colorectal cancer was detected during the index colonoscopy and confirmed by histopathological examination. |
| Secondary | Endoscopist satisfaction | Immediately after completion of colonoscopy. | Endoscopist-reported satisfaction with procedural conditions assessed using a 11-point numerical rating scale, with higher scores indicating greater satisfaction. |
| Secondary | Incidence of clinically relevant cardiovascular adverse events | From administration of sedation through completion of monitored post-procedural recovery on the day of colonoscopy. | Incidence of protocol-defined cardiovascular adverse events, reported by event type, including systolic blood pressure below 90 mmHg, heart rate below 50 or above 110 beats per minute, and clinically relevant arrhythmias. |
| Secondary | Depth of sedation assessed by qCON | From baseline before sedation through completion of the colonoscopy, assessed at predefined intervals. | Depth of sedation assessed using the qCON index derived from processed electroencephalographic monitoring. qCON values range from 0 to 99, with lower values indicating deeper levels of sedation or hypnosis. |
| Secondary | Nociception-related response assessed by qNOX | From baseline before sedation through completion of the colonoscopy, assessed at predefined intervals. | Nociception-related response assessed using the qNOX index derived from processed electroencephalographic monitoring. qNOX values range from 0 to 99, with lower values indicating a lower probability of response to noxious stimulation. |
| Secondary | Clinical depth of sedation | From administration of sedation through completion of the colonoscopy. | Clinical depth of sedation assessed using the Modified Wilson Sedation Scale at predefined intervals during the procedure. |
| Secondary | Patient anxiety assessed using the Endler Multidimensional Anxiety Scales (EMAS) | At the initial study interview, immediately before colonoscopy, and 48-72 hours after colonoscopy. | Patient anxiety was assessed using the Endler Multidimensional Anxiety Scales (EMAS). Trait anxiety was assessed using the EMAS-T during the initial study interview. State anxiety was assessed using the EMAS-S immediately before colonoscopy and again 48-72 hours after the procedure. |
| Secondary | Patient pain assessed using the Brief Pain Inventory (BPI) | At the initial study interview, immediately before colonoscopy, and 48-72 hours after colonoscopy. | Patient-reported pain was assessed using the Brief Pain Inventory (BPI). The long form was completed during the initial study interview, while the short form was completed immediately before colonoscopy and again 48-72 hours after the procedure. BPI measures pain severity and pain-related interference, with higher scores indicating greater pain severity or interference. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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