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Completed

NCT Number: NCT01840371

Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)

The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.

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Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patients who scheduled for ERCP

Exclusion criteria

  • The patients with ASA physical classification V
  • The patients with history of sulfite, egg or soy bean allergy
  • The patients during pregnancy or latency period
  • The patients who informed consent could not be obtained
  • The patients who were under 20 years old

Treatment and study plan

Conventional sedation

Drug

Propofol Meperidine : 25 mg IV just before procedure

  • IV bolus of 1 mg/kg for sedation induction,
  • Infusion of 60 mcg/min/kg for maintenance of sedation
  • Additional bolus dose of 10mg as needed for adequate sedation

Experimental sedation

Drug

Fentanyl

  • IV bolus of 1 µg/kg for sedation induction
  • Additional bolus dose of 0.5 µg/kg as needed for adequate pain control Propofol
  • IV bolus of 0.4 mg/kg for sedation induction
  • Infusion of 30 µg/min/kg for maintenance of sedation
  • Additional bolus dose of 10mg as needed for adequate depth of sedation

Primary outcomes

  1. Recovery time

    Time frame: time from scope withdrawal to full recovery at averange 24 hours

    Recovery time (time from scope withdrawal to full recovery)

Secondary outcomes

  1. Adverse event during and after procedure

    Time frame: measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours

    Adverse event during and after procedure i. Desaturation rate ii. Apnea

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2013
Registry last updated
Jun 4, 2014

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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