Disorders of Gallbladder, Biliary Tract and Pancrease
Conditions
Keywords
Propofol, Midazolam, Meperidine
Brief summary
The purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP
Detailed description
ERCP is commonly done under sedation with midazolam and meperidine, however some studies showed varying outcomes of this conventional sedation for maintained sedation. Propofol is increasing used for sedation in gastrointestinal procedure owing to its rapid recovery profiles but the complications associated with propofol are not negligible.The investigators prospectively compare the efficacy, induction time, recovery time, patient satisfaction and side effect between propofol based and conventional sedations in patients undergoing ERCP.
Interventions
DRUGPropofol
Propofol is the sedative drug used as an additional sedation to one of the study arm.
DRUGMidazolam
Midazolam is one of the two conventional sedative drugs included in both arms.
DRUGMeperidine
Meperidine is one of the two conventional sedative drugs included in both arms.
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
. All outpatients aged more than 18 years who were schedule for ERCP -
Exclusion criteria
* pregnant woman * emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute cholangitis ) * American Society of Anesthesiologist ( ASA )Class IV or V * respiratory disease, * sleep apnea * allergy to egg or soybean * drug abuse( benzodiazepine, opioid agonist ) * previous history of failure sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Related Time | participants will be followed for the duration of procedure, an expected average of 2.0 hours ] | (1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Adverse Events. | participants will be followed for the duration of procedure, an expected average of 2.0 hours | (1) desaturation(oxygen saturation \< 90 % at least 10 second ) (2) hypotension ( systolic blood pressure \< 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate \< 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation \< 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea. |
Countries
Thailand
Participant flow
Recruitment details
Patients who were schedule for endoscopic retrograde cholangiopancreatography in NKC Institute ,Prince of Songkla University during January 2010-December 2011
Pre-assignment details
Patients were excluded from the final analysis if the procedure was terminated due to technical reasons prior to attempted cannulation.
Participants by arm
| Arm | Count |
|---|---|
| Propofol,Midazolam and Meperidine The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. | 70 |
| Midazolam and Meperidine The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Midazolam and Meperidine | Propofol,Midazolam and Meperidine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 23 Participants | 56 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 47 Participants | 84 Participants |
| Age Continuous | 61.31 years STANDARD_DEVIATION 16.52 | 55.77 years STANDARD_DEVIATION 17.35 | 58.54 years STANDARD_DEVIATION 17.11 |
| Region of Enrollment Thailand | 70 participants | 70 participants | 140 participants |
| Sex: Female, Male Female | 34 Participants | 38 Participants | 72 Participants |
| Sex: Female, Male Male | 36 Participants | 32 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 70 | 40 / 70 |
| serious Total, serious adverse events | 1 / 70 | 0 / 70 |
Outcome results
Primary
Procedure Related Time
(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.
Time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]
Population: Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propofol,Midazolam and Meperidine | Procedure Related Time | procedure time | 40.67 minutes | Standard Deviation 27.5 |
| Propofol,Midazolam and Meperidine | Procedure Related Time | induction time | 3.94 minutes | Standard Deviation 2.18 |
| Propofol,Midazolam and Meperidine | Procedure Related Time | recovery time | 24.71 minutes | Standard Deviation 23.03 |
| Midazolam and Meperidine | Procedure Related Time | procedure time | 43.24 minutes | Standard Deviation 31.35 |
| Midazolam and Meperidine | Procedure Related Time | induction time | 5.47 minutes | Standard Deviation 2.51 |
| Midazolam and Meperidine | Procedure Related Time | recovery time | 88.50 minutes | Standard Deviation 54.62 |
p-value: 0.05t-test, 2 sided
Secondary
Cardiovascular Adverse Events.
(1) desaturation(oxygen saturation \< 90 % at least 10 second ) (2) hypotension ( systolic blood pressure \< 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate \< 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation \< 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.
Time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours
Population: Intention to treat population include participants who received sedative agents and underwent ERCP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propofol,Midazolam and Meperidine | Cardiovascular Adverse Events. | Participants with hypotension | 12 Participants |
| Propofol,Midazolam and Meperidine | Cardiovascular Adverse Events. | Participants with bradycardia | 1 Participants |
| Propofol,Midazolam and Meperidine | Cardiovascular Adverse Events. | Participants with desatuartion | 26 Participants |
| Midazolam and Meperidine | Cardiovascular Adverse Events. | Participants with hypotension | 14 Participants |
| Midazolam and Meperidine | Cardiovascular Adverse Events. | Participants with bradycardia | 0 Participants |
| Midazolam and Meperidine | Cardiovascular Adverse Events. | Participants with desatuartion | 40 Participants |
p-value: 0.05Chi-squared