Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Conscious Sedation Failure During Procedure
- Sponsor
- Soon Chun Hyang University
- Enrollment
- 204
- Primary Endpoint
- Recovery time and cost-effectiveness
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Propofol group
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).
Intervention: Propofol
BPS group
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.
Intervention: BPS
Outcomes
Primary Outcomes
Recovery time and cost-effectiveness
Time Frame: SIX MONTH
Following therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.
Secondary Outcomes
- Sedation efficacy, procedure-related outcomes, and complications.(SIX MONTH)