Recuperation between 2 types of sedation after colonoscopy.

A psychomotor recuperation study after deep sedation for colonoscopy between target controlled and manual titration of propofol.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005215-16-BE

Enrollment

160

Registered

2015-01-15

Start date

2015-02-13

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory colonoscopy with sedation by target controlled infusion or manual titration of propofol. MedDRA version: 19.0 Level: LLT Classification code 10010010 Term: Colonoscopy and sigmoidoscopy normal System Organ Class: 100000004848

Interventions

Trade Name: DIPRIVAN 1% : propofol10 mg/ml Product Name: Diprivan Pharmaceutical Form: Injection INN or Proposed INN: PROPOFOL Other descriptive name: PROPOFOL Concentration unit: mg/ml milligram(s)/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients subjected to deep sedation in ambulant care ASA status 1-3 18-80 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: Language barrier. Dementia. Gastroscopy planned at the same time. Allergies to propofol. All cases were a ‘full stomach’ is suspected (gastric banding) Pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Our aim is to evaluate efficacy and recovery after manual titration and target controlled infusion (TCI) of propofol, during colonoscopy, for ambulatory patients. We will evaluate both groups during and after colonoscopy for adverse events, quality of sedation and recovery of psychomotor function. ;Secondary Objective: Not applicable;Primary end point(s): - Differences in ‘fit for discharge’ time (10 minutes difference in fit for discharge time);Timepoint(s) of evaluation of this end point: up to 60 minutes after colonoscopy cessation	—

Measure

Time frame

Main Objective: Our aim is to evaluate efficacy and recovery after manual titration and target controlled infusion (TCI) of propofol, during colonoscopy, for ambulatory patients. We will evaluate both groups during and after colonoscopy for adverse events, quality of sedation and recovery of psychomotor function. ;Secondary Objective: Not applicable;Primary end point(s): - Differences in ‘fit for discharge’ time (10 minutes difference in fit for discharge time);Timepoint(s) of evaluation of this end point: up to 60 minutes after colonoscopy cessation

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Secondary

Measure	Time frame
Secondary end point(s): - Differences in clinical evaluation and test scores at discharge. - Differences in the scores of the tests before and after sedation. - Differences in evaluation of sedation by gastroenterologist and patient. - Differences in total propofol/kg consumption and per unit of time/kg. - Differences in time to eye-opening. 10 % difference in test scores between the 2 groups 10% difference in test scores before and after sedation ;Timepoint(s) of evaluation of this end point: up to 60 minutes after colonoscopy cessation	—

Measure

Time frame

Secondary end point(s): - Differences in clinical evaluation and test scores at discharge. - Differences in the scores of the tests before and after sedation. - Differences in evaluation of sedation by gastroenterologist and patient. - Differences in total propofol/kg consumption and per unit of time/kg. - Differences in time to eye-opening. 10 % difference in test scores between the 2 groups 10% difference in test scores before and after sedation ;Timepoint(s) of evaluation of this end point: up to 60 minutes after colonoscopy cessation

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Countries

Belgium

Contacts

Public ContactAnesthesiology Service

CHU Brugmann

Philippe.VANDERLINDEN@chu-brugmann.be32024773996

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026