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OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde cholangiopancreatography) METHODS:This randomized and double blind study was performed with forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned. Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who were randomly divided into two premedication groups.
Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was considered as cognitive impairment. Recovery period, post-procedure state of cognitive function at 60th minute were recorded.
The Outcome Measures are number of Participants with Adverse Events, and the incidence of Postoperative cognitive dysfunction assessed by MMT (mini-mental test) in first 60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tramadol | Active Comparator | 1mg/kg of tramadol drop (Contramal® drop, Abdi Ibrahim Ilaç San.,istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, Group T who were separated randomly to two premedication groups. |
|
| midazolam | Active Comparator | 0.15 mg/kg of midazolam (Dormicum®, ampoule, Roche Products A.Ş., istanbul) was administered orally in 10 mL of cherry juice without particles in preparation room before intervention, to Group M who were separated randomly to two premedication groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | GROUP T |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The early cognitive functions after ERCP | The early cognitive functions after ERCP assessed by mini-mental test (MMT) | Postprocedure in the first 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | With any side effects | Postprocedure in first 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Arslan, Prof.Dr. | Gastroenterology Department | Study Chair |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Midazolam |
| Drug |
GROUP M |
|
|
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |