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

Conscious Sedation Failure During Procedure Clinical Trial

— ERCP  

Official title:

Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01321047
• Other study ID #: SCH-2011-18
• Status: Unknown status
• Phase: Phase 4
• First received: March 22, 2011
• Last updated: March 22, 2011
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2011
• Source: Soon Chun Hyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 204
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conscious Sedation Failure During Procedure

Intervention

Drug:
• Propofol
propofol (0.5 mg/kg body weight; 10 mg if age > 70 or ASA class III-IV)
• BPS
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soon Chun Hyang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery time and cost-effectiveness	Following therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.	SIX MONTH
Secondary	Sedation efficacy, procedure-related outcomes, and complications.	Sedation 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.	SIX MONTH