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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | both midazolam (1mg if aged <= 70 years or 0.5mg in age >70 years) and meperidine 20 mg were given intravenously at the initiation of sedation, Thereafter, an initial bolus of propofol 20 mg intravenously. Sedation was maintained with repeated dose of 5 to 10 mg propofol. |
|
| Conventional | Active Comparator | both midazolam 2 to 5 mg and meperidine 25 to 50 mg were given intravenously at the initiation of sedation. Sedation was maintained with repeated doses of 0.5 to 1.0 mg midazolam and 5 to 10 mg meperidine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol is the sedative drug used as an additional sedation to one of the study arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | participants will be followed for the duration of procedure, an expected average of 2.0 hours ] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
. All outpatients aged more than 18 years who were schedule for ERCP -
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nisa Netinatsunton, MD | NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University | Principal Investigator |
| Nisa Netinatsunton, MD | Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
Patients were excluded from the final analysis if the procedure was terminated due to technical reasons prior to attempted cannulation.
Patients who were schedule for endoscopic retrograde cholangiopancreatography in NKC Institute ,Prince of Songkla University during January 2010-December 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | 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. |
| FG001 | Conventional | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Midazolam and Meperidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat population include participants who received sedative agents and underwent ERCP. | Posted | Number | Participants | participants will be followed for the duration of procedure, an expected average of 2.0 hours |
|
1 month
ERCP complications and sedation related complications are assessed one month after the procedure date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe bradycardia | Cardiac disorders | ERCP complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | ERCP complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nisa Netinatsunton | Prince of Songkhla University | 6674451965 | 9 | nisasan@yahoo.com |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D008874 | Midazolam |
| D001569 | Benzodiazepines |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Midazolam | Drug | Midazolam is one of the two conventional sedative drugs included in both arms. |
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| Meperidine | Drug | Meperidine is one of the two conventional sedative drugs included in both arms. |
|
|
| participants will be followed for the duration of procedure, an expected average of 2.0 hours |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.
| OG001 | 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 to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit. |
|
|
|
| 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. | Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP). | Posted | Mean | Standard Deviation | minutes | participants will be followed for the duration of procedure, an expected average of 2.0 hours ] |
|
|
|
|
| 1 |
| 70 |
| 26 |
| 70 |
| EG001 | 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 | 0 | 70 | 40 | 70 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| recovery time |
|