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Balanced Propofol Sedation Versus Propofol Alone Sedation in Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)

Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01321047
Acronym
ERCP
Enrollment
204
Registered
2011-03-23
Start date
2011-04-30
Completion date
2011-10-31
Last updated
2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation Failure During Procedure

Keywords

sedation, benzodiazepine, opioid, propofol

Brief summary

Based on previous results, the investigators considered that sedation quality, complications, and procedure outcomes may not be different, however, propofol alone titration may have a fast recovery time than BPS and cost-effectiveness than balanced propofol sedation (BPS). In present study, the investigators therefore evaluate the time and sedation quality of patient recovery, cost-effectiveness, complication, and procedure outcomes between propofol alone and BPS in therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

Detailed description

Previous studies have shown that propofol is superior to traditional sedation regimens with benzodiazepines plus opioids in ERCP procedures. Propofol is a potent hypnotic drug with a short duration of action and consequently a more rapid recovery time for the patients compared with the available Benzodiazepines. Several prospective studies have shown that balanced propofol sedation (BPS) can be used safely and effectively for diagnostic endoscopy under the direction of a gastroenterologist. BPS which was originally described by Cohen et al, combines small incremental doses of propofol with single induction doses of benzodiazepines and opioids under the direction of a physician that is not an anesthesiologist. Because BPS usually targets moderate sedation, adequate amnesia and analgesia can be achieved with concomitant administration of benzodiazepines and opioids. It may cause synergism between propofol and midazolam and reduce dose of propofol. However, there was no proven benefit between propofol alone titrated to moderate level of sedation and BPS; propofol titration combination with benzodiazepines and fentanyl.

Interventions

DRUGPropofol

propofol (0.5 mg/kg body weight; 10 mg if age \> 70 or ASA class III-IV)

DRUGBPS

midazolam (0.05 mg/kg body weight; 1 mg if age \> 70 or ASA class III-IV) fentanyl (50 µg; 25 µg if age \> 70 or ASA class III-IV) propofol (0.5 mg/kg body weight)

Sponsors

Soon Chun Hyang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* candidates for therapeutic ERCP

Exclusion criteria

* patient age \< 18 years * pregnant women * inability to provide informed consent * patients with total gastrectomy * American Society of Anesthesiologist (ASA) Class V patients * patients with known respiratory disease, patients with neurologic impairment * patients with known allergy to the drugs used, history of complications with previous sedation

Design outcomes

Primary

MeasureTime frameDescription
Recovery time and cost-effectivenessSIX MONTHFollowing therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.

Secondary

MeasureTime frameDescription
Sedation efficacy, procedure-related outcomes, and complications.SIX MONTHSedation efficacy parameters was defined as follows; Onset of effective sedation, Patient cooperation (endoscopist, observer-nurse), recovery time, and Patient tolerance (rated by the patients 4hr after procedure). Quality of procedure was assessed by procedure outcomes and procedure related complications.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026