Disorders of Gallbladder, Biliary Tract and Pancreas
Conditions
Keywords
Cocktail sedation, ERCP
Brief summary
Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and may result in a lower risk of oversedation. The investigators prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.
Detailed description
ERCP patients were prospectively randomized into 2 groups; the cocktail group and the controls. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were injected in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.
Interventions
DRUGpropofol
For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, one milligram per kilogram body weight of 1% propofol emulsion (Baxter Healthcare Corp., Irvine, CA) was slowly infused by an automated pump (Terufusion syringe pump TE-331, Terumo Corporation, Tokyo, Japan). To maintain conscious level of patient in the conventional group to be at moderate or deep level, 25 mg of meperidine and/or 2.5 mg of midazolam were administered as necessary, whereas patients in the cocktail group were continuously administered with 1% propofol at the rate of 1 mg/kg/hr. An additional 0.5 mg/kg bolus was administered as needed to achieve the designed conscious level.
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for ERCP
Exclusion criteria
* Age under 18 years * American Society of Anesthesiologists' (ASA) physical classification IV - V * History of sulfite, egg or soy bean allergy * Emergency need for ERCP * Informed consent could not be obtained
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| procedure related time | participants will be followed for the duration of procedure, an expected average of 1.5 hours | (1) induction time (the time from sedation to scope intubation), (2) procedural time (the time from scope intubation to scope withdrawal), and (3) recovery time (the time from scope withdrawal to full recovery (modified Aldrete score of 10)). The induction time and procedural time were recorded by the nurse in the endoscopy unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary complications | participants will be followed for the duration of procedure, an expected average of 1.5 hours | (1) hypotension (systolic blood pressure drops to less than 90 mmHg or decreases more than 25% from the baseline), (2) bradycardia (heart rate \<40 beats/min), (3) desaturation (oxygen saturation \<90% for \>10 seconds), and (4) apnea (cessation of respiratory activity for over 10 seconds under visual observation). If the oxygen saturation dropped to \<85% for more than 30 seconds despite oxygen supplementation or apnea occurred, the procedure would be interrupted and reversal medications would be given to the patient. |
Countries
Thailand
Outcome results
None listed