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Completed

NCT Number: NCT01505218

Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography (ERCP). Combination of sedatives and opioids is associated with increased morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative studies with PCS for ERCP are few. Therefore, the main objective of this randomized controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists during ERCP.

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Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University Hospital

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Need for ERCP
  • Able to speak and read swedish

Exclusion criteria

  • Allergy to propofol
  • Severe cardiopulmonary disease (ASA IV)
  • Confusion or dementia

Treatment and study plan

Propofol sedation by nurse anaesthestist

Drug

Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation.

Patient-controlled sedation: self-administration of propofol boluses of 5 mg with zero lock-out time. Administration time for the pump was 12 sec, equivalent to maximum delivery of 25 mg of propofol per minute.

Propofol sedation by nurse anaesthetists:

Patient-controlled propofol sedation

Drug

Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation.

Self-administration of propofol via patient-controlled sedation pump (CME T-34L PCA). No programmed lock-out period, no dose limit or background infusion. 5 mg propofol/effectuated demand from the patients. Capacity of the pump was 6 possible doses per minute.

Before start of ERCP the patients were allowed to sedate themselves to a sense of heavy tiredness.

Primary outcomes

  1. treatability

    Time frame: one day (per-procedural)

    Registration of number of failures (where procedure is interrupted as a result of inadequate sedation). Comparison data between propofol PCS and nurse anaesthetists sedation using propofol and control group (midazolam).

Secondary outcomes

  1. Vital signs

    Time frame: one and a half year

    Vital signs and interventions of nurse anaesthetists. Data on heart rate, blood pressure, peripheral oxygen saturatuion, respiratory rate, delivery of oxygen, airway obstruction assessment, airway manipulation.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography

Acronym: PER-projekt

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2012
Registry last updated
Nov 9, 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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