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Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids

NCT01304342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2013-08-05

No results posted yet for this study

Summary

Addition of fentanyl or remifentanil to the propofol produced sedation for scheduled ERCP will decrease the propofol requirements for predetermined sedation levels (as shown by Bispectral Index Monitor (BIS) monitor), will be associated with faster recovery monitored by Ramsay's and Observer's Assessment of Alertness/Sedation (OAAS) scores and BIS, less postoperative pain (assessed by Visual Analogue Scale=VAS) and less early cognitive impairment after sedation (as assessed by the MiniMental test).

Conditions

Interventions

DRUG

Remifentanil

1 microgram/kg/h, continuous infusion, 5 min before and during the ERCP

DRUG

Fentanyl

Intranasal fentanyl 200 micrograms 5 min before the ERCP

DRUG

Normal saline

Normal saline intravenously and intranasally

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01304342 on ClinicalTrials.gov