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Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT ID: NCT01079312

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

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Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.

Detailed Description

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80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.

Conditions

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Endoscopic Retrograde Cholangiopancreatography

Keywords

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ERCP patient-controlled sedation propofol remifentanil sedation level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol infusion

Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml

Group Type ACTIVE_COMPARATOR

infusion pump

Intervention Type DEVICE

anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level

propofol

Intervention Type DRUG

Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.

fentanyl

Intervention Type DRUG

Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.

Patient-controlled sedation

self-administration of propofol and remifentanil mixture during ERCP

Group Type ACTIVE_COMPARATOR

infusion pump for patient-controlled sedation

Intervention Type DEVICE

self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.

propofol

Intervention Type DRUG

Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.

sedative mixture

Intervention Type DRUG

Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)

remifentanil hydrochlorid

Intervention Type DRUG

Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)

Interventions

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infusion pump

anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level

Intervention Type DEVICE

infusion pump for patient-controlled sedation

self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.

Intervention Type DEVICE

propofol

Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.

Intervention Type DRUG

fentanyl

Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.

Intervention Type DRUG

sedative mixture

Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)

Intervention Type DRUG

remifentanil hydrochlorid

Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)

Intervention Type DRUG

Other Intervention Names

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-Braun AG -an infusion pump -Arcomed,Syramed AG,Switzerland -infusion pump designed for self administration of the drugs -Diprivan -Recofol -Fresofol -fentanyl citrate -fentanyl -Ultiva -Diprivan -Ultiva

Eligibility Criteria

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Inclusion Criteria

* elective ERCP-patients

Exclusion Criteria

* allergy to propofol or opioid;
* ASA-class (American Society of Anaesthesiology) greater than 3;
* inability to co-operate;
* drugs abuse.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maxim Mazanikov

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maxim Mazanikov, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Anaesthesiology

Marianne Udd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Outi Lindström, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Leena Kylänpää, Docent

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Pekka Aho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Vascular Surgery

Jorma Halttunen, Docent

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Martti Färkilä, Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gasroenterology

Reino Pöyhiä, Docent

Role: STUDY_CHAIR

Helsinki University Central Hospital,Department of Anaesthesiology

Locations

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Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

References

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Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.

Reference Type RESULT
PMID: 21295639 (View on PubMed)

Other Identifiers

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2008-007968-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

a001c

Identifier Type: -

Identifier Source: org_study_id