PER-projekt: Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

Sponsor

University Hospital, Linkoeping (Other)

Overall Status

Completed

CT.gov ID

NCT01505218

Collaborator

(none)

281

Enrollment

Location

Arms

Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography	Drug: Propofol sedation by nurse anaesthestist Drug: Patient-controlled propofol sedation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

281 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propofol sedation by nurse anaesthetist Nurse anaesthetists managed infusion of propofol 10 mg/ml at doses of 0.2 - 0.8 ml/kg during ERCP. The target of moderate sedation was achieved within 5 minutes from start of the sedation.	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:
Active Comparator: Patient-controlled propofol sedation Self-administration of propofol via patient-controlled sedation pump (CME...). 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.	Drug: 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.
No Intervention: Midazolam sedation by the ERCP-team Midazolam doses for sedation during ERCP. Initial dose of 2-3 mg and after ERCP start, 1-2 mg as additional doses. Maximum total dose 6-8 mg. ERCP performing doctor is responsible for dose ordination.

Arm

Intervention/Treatment

Active Comparator: Propofol sedation by nurse anaesthetist

Nurse anaesthetists managed infusion of propofol 10 mg/ml at doses of 0.2 - 0.8 ml/kg during ERCP. The target of moderate sedation was achieved within 5 minutes from start of the sedation.

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:

Active Comparator: Patient-controlled propofol sedation

Self-administration of propofol via patient-controlled sedation pump (CME...). 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.

Drug: 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.

No Intervention: Midazolam sedation by the ERCP-team

Midazolam doses for sedation during ERCP. Initial dose of 2-3 mg and after ERCP start, 1-2 mg as additional doses. Maximum total dose 6-8 mg. ERCP performing doctor is responsible for dose ordination.

Outcome Measures

Primary Outcome Measures

treatability [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 Outcome Measures

Vital signs [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Need for ERCP
Able to speak and read swedish

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linköping University Hospital	Linköping		Sweden	581 85

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

Study Chair: Folke Sjöberg, Professor, Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lena Nilsson, MD, PhP, senior consultant, University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT01505218

Other Study ID Numbers:

PER 2010/232-31

First Posted:

Jan 6, 2012

Last Update Posted:

Nov 9, 2020

Last Verified:

Dec 1, 2015

Keywords provided by Lena Nilsson, MD, PhP, senior consultant, University Hospital, Linkoeping

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Nov 9, 2020