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Trial · NCT06208956

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe primary outcome is the incidence of hypotensionThe time during colonoscopy, an average of 15 minutesHypotension is defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP \< 90, and/or DBP \< 50 mmHg
SecondaryArea under the threshold (AUT) of hypotensionThe time during colonoscopy, an average of 15 minutes
AUT=depth of hypotension below (a 20% decrease in baseline SBP or DBP) or (90 mm Hg of SBP or 50 mm Hg of DBP)× time in minutes spent of hypotension. As an example, a patient undergoes colonoscopy that lasts 15 min, in which he experiences 2 episodes of hypotension, all lasting for 1 min and all with a minimal SBP of 80 mm Hg. The AUT = 2 min × (90 -80= 10 mm Hg under the SBP threshold of 90 mm Hg) = 2×10 = 20 mm Hg per minute.
SecondaryTime-weighted average (TWA)The time during colonoscopy, an average of 15 minutesTWA is calculated as the AUT divided by the total duration of colonoscopy
SecondaryCumulative duration of hypotensionThe time during colonoscopy, an average of 15 minutesThe total time of patients experience hypotenion(hpotension defined as 20% decrease from baseline systolic blood pressure (SBP) or diastolic blood pressure (DBP), or SBP \< 90, and/or DBP \< 50 mmHg)
SecondaryMaximum reduction in blood pressure (BP)The time during colonoscopy, an average of 15 minutesMaximum reduction in systolic blood pressure (SBP) ,diastolic blood pressure (DBP) and mean arterial pressure (MAP) from baseline
SecondaryThe incidence of bradycardiaThe time during colonoscopy, an average of 15 minutesBradycardia is defined as heat rate(HR) \<50 beats/min
SecondaryThe incidence of hypoxemiaThe time during colonoscopy, an average of 15 minutesHypoxemia is defined as oxygen saturation (SpO2)\<90%
SecondaryThe body movementThe time during colonoscopy, an average of 15 minutesThe twisting of the patient's body due to the stimulation of the colonoscopy, making it difficult to proceed with the procedure
SecondaryDischarge timeFrom the end of colonoscopy to discharge,an average of 40 minutesFrom the end of colonoscopy to discharge
SecondaryPatients satisfaction scoreWhen the patient is fully awake after colonoscopy,an average of 5 minutesUsing an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"
SecondaryEndoscopists'satisfaction scoreAt the end of colonoscopy,an average of 15 minutesUsing an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"
SecondaryThe incidence of dizzinessFrom the end of colonoscopy to discharge,an average of 40 minutesThe investigators consider it dizziness if patients fell any dizziness
SecondaryThe incidence of fatigueFrom the end of colonoscopy to discharge,an average of 40 minutesThe investigators consider it fatigue if patients fell any fatigue
SecondaryThe incidence of nausea and vomitingFrom the end of colonoscopy to discharge,an average of 40 minutesThe investigators consider it nausea and vomiting if patients fell any nausea and vomiting

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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