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

NCT01321047 | Unknown Phase 4 DMC

• 1 other identifier: SCH-2011-18
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Conscious Sedation Failure During Procedure

Keywords

sedation; benzodiazepine; opioid; propofol

Outcome Measures

Primary Outcomes (1)

• Recovery time and cost-effectiveness

  Following therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.

  SIX MONTH

Secondary Outcomes (1)

• Sedation efficacy, procedure-related outcomes, and complications.

  SIX MONTH

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

the conventional propofol group (P group), sedation was induced by an intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age \> 70 or ASA class III-IV).

Drug: Propofol

BPS group

ACTIVE COMPARATOR

the balanced propofol sedation group (BPS group), both midazolam (0.05 mg/kg body weight; 1 mg if age \> 70 or ASA class III-IV) and fentanyl (50 µg; 25 µg if age \> 70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, an initial bolus of propofol (0.5 mg/kg body weight) was given intravenously. Sedation was maintained with repeated doses of 10 to 20 mg propofol.

Drug: BPS

Interventions

Propofol DRUG

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

Also known as: A GROUP

Propofol group

BPS DRUG

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)

Also known as: B GROUP

BPS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• candidates for therapeutic ERCP

You may not qualify if:

• 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

Sponsors & Collaborators

• Soon Chun Hyang University: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tae Hoon Lee, MD

  Soonchunhyang University College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 23, 2011

Record last verified: 2011-03