A Psychomotor Recuperation Study After Deep Sedation for Colonoscopy Between Target Controlled and Manual Titration of Propofol

NCT02314559 | Completed Phase 4

• 1 other identifier: CHUB Mental Recup 001
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Deep sedation with propofol for ambulatory colonoscopy has become standard clinical practice.To achieve the necessary (e.g.: no excessive movement and no awareness) level of sedation during colonoscopy, propofol can be titrated by hand, continuous infusion or by target controlled infusion. The aim of the investigators is to evaluate sedation efficacy and recovery between two groups of ambulatory patients having a colonoscopy: one group will receive a manual titration of propofol, the other group a target controlled infusion (TCI) of propofol. The investigators will evaluate both groups before, during and after colonoscopy for adverse events, quality of sedation and recovery. When patients are estimated to be ready for discharge, they will also be subjected to a cognitive and a psychomotoricity test.

Conditions

Colonoscopy (Ambulatory Patients)

Keywords

propofol; colonoscopy

Outcome Measures

Primary Outcomes (3)

• Digit Symbol Substitution test score

  The digit symbol substitution test score wil be compared between the propofol manual titration and the propofol target controled infusion groups. This test will evaluate cognitive function.

  24 hours

• PADS score

  Time and fitness to discharge will be evaluated with the PADS score. This will be done at discharge of the patient, after the colonoscopy.

  24 hours

• Choice reaction time test score

  The choice reaction time test score will be compared between the propofol manual titration and the propofol target controlled infusion groups. The groups will be tested before the colonoscopy and every 10 minutes after waking up, up to the discharge of the patient. This test is used to evaluate the psychomotoricity of the patients.

  24 hours

Study Arms (2)

Propofol (manual titration)

EXPERIMENTAL

Drug: Manual titration of propofol

Propofol (target controlled infusion)

ACTIVE COMPARATOR

Drug: Target controlled infusion of propofol

Interventions

Manual titration of propofol DRUG

One group will be sedated with a manual titration technique: here the titration of propofol is done manually by the anesthetist. Dosages may range between 50 and 400mg, given by boluses of 20-50mg.

Propofol (manual titration)

Target controlled infusion of propofol DRUG

The other group will be sedated with a target controlled infusion technique (pump, marsh or Schneider). The anesthetist can titrate indirectly by adjusting the target controlled infusion to achieve adequate sedation. The concentrations of propofol may vary between 2 and 6 µg/ml, achieved by increments of 0.5-1.5 µg/ml.

Propofol (target controlled infusion)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients subjected to deep sedation in ambulant care, having a colonoscopy
• ASA 1-3

You may not qualify if:

• Dementia.
• Gastroscopy planned at the same time.
• Allergies to propofol
• All cases were a 'full stomach' is suspected (gastric banding)
• Pregnancy

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (12)

• Riphaus A, Geist F, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: re-evaluation from the first nationwide survey 3 years after the implementation of an evidence and consent based national guideline. Z Gastroenterol. 2013 Sep;51(9):1082-8. doi: 10.1055/s-0033-1335104. Epub 2013 Sep 10.

  PMID: 24022202 BACKGROUND

• Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.

  PMID: 16573781 BACKGROUND

• Carlsson U, Grattidge P. Sedation for upper gastrointestinal endoscopy: a comparative study of propofol and midazolam. Endoscopy. 1995 Mar;27(3):240-3. doi: 10.1055/s-2007-1005678.

  PMID: 7664702 BACKGROUND

• Qadeer MA, Vargo JJ, Khandwala F, Lopez R, Zuccaro G. Propofol versus traditional sedative agents for gastrointestinal endoscopy: a meta-analysis. Clin Gastroenterol Hepatol. 2005 Nov;3(11):1049-56. doi: 10.1016/s1542-3565(05)00742-1.

  PMID: 16271333 BACKGROUND

• Riphaus A, Gstettenbauer T, Frenz MB, Wehrmann T. Quality of psychomotor recovery after propofol sedation for routine endoscopy: a randomized and controlled study. Endoscopy. 2006 Jul;38(7):677-83. doi: 10.1055/s-2006-925244.

  PMID: 16810592 BACKGROUND

• Horiuchi A, Nakayama Y, Katsuyama Y, Ohmori S, Ichise Y, Tanaka N. Safety and driving ability following low-dose propofol sedation. Digestion. 2008;78(4):190-4. doi: 10.1159/000187118. Epub 2008 Dec 18.

  PMID: 19092246 BACKGROUND

• Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.

  PMID: 21072716 BACKGROUND

• Chiang MH, Wu SC, You CH, Wu KL, Chiu YC, Ma CW, Kao CW, Lin KC, Chen KH, Wang PC, Chou AK. Target-controlled infusion vs. manually controlled infusion of propofol with alfentanil for bidirectional endoscopy: a randomized controlled trial. Endoscopy. 2013 Nov;45(11):907-14. doi: 10.1055/s-0033-1344645. Epub 2013 Oct 28.

  PMID: 24165817 BACKGROUND

• Grant SA, Murdoch J, Millar K, Kenny GN. Blood propofol concentration and psychomotor effects on driving skills. Br J Anaesth. 2000 Sep;85(3):396-400. doi: 10.1093/bja/85.3.396.

  PMID: 11103180 BACKGROUND

• Grant SA, Millar K, Kenny GN. Blood alcohol concentration and psychomotor effects. Br J Anaesth. 2000 Sep;85(3):401-6. doi: 10.1093/bja/85.3.401.

  PMID: 11103181 BACKGROUND

• Trevisani L, Cifala V, Gilli G, Matarese V, Zelante A, Sartori S. Post-Anaesthetic Discharge Scoring System to assess patient recovery and discharge after colonoscopy. World J Gastrointest Endosc. 2013 Oct 16;5(10):502-7. doi: 10.4253/wjge.v5.i10.502.

  PMID: 24147194 BACKGROUND

• Deary IJ, Liewald D, Nissan J. A free, easy-to-use, computer-based simple and four-choice reaction time programme: the Deary-Liewald reaction time task. Behav Res Methods. 2011 Mar;43(1):258-68. doi: 10.3758/s13428-010-0024-1.

  PMID: 21287123 BACKGROUND

Study Officials

• Denis Schmartz, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesiology department

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 11, 2014
• Study Start: February 1, 2015
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)