Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

— PER-projekt  

Official title:

Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505218
• Other study ID #: PER 2010/232-31
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: December 2015
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Need for ERCP

• Able to speak and read swedish

Exclusion Criteria:

• Allergy to propofol

• Severe cardiopulmonary disease (ASA IV)

• Confusion or dementia

Related Conditions & MeSH terms

• Endoscopic Retrograde Cholangiopancreatography

Intervention

Drug:
• Propofol sedation by nurse anaesthestist
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
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.

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatability	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).	one day (per-procedural)
Secondary	Vital signs	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.	one and a half year