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Completed

NCT Number: NCT01072435

Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).

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Key information

Conditions

Sedation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit

Helsinki, Uusimaa, 00029, Finland

About this study

80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective ERCP patients

Exclusion criteria

  • allergy to propofol or opioid;
  • inability to cooperate;
  • ASA(American Society of Anaesthesiology)class greater than 3

Treatment and study plan

Patient-controlled sedation

Device

Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.

Other names: Arcomed/Syramed AG infusion pump designed for self administration of medicines

Target-controlled infusion

Device

Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol

Other names: Arcomed/Syramed AG target-controlled infusion device.

Primary outcomes

  1. sedation degrees

    Time frame: One day

  2. patient's and endoscopist´s satisfaction,

    Time frame: One day

  3. propofol consumption

    Time frame: One day

  4. vital signs:oxygen saturation,blood pressure,heart rate,breathing rate

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 22, 2010
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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