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This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.
This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCI propofol | Active Comparator | Target controlled infusion propofol titrated by the investigator intra-procedure, based on the Modified Observer's Assessment of Alertness and Sedation Scale |
|
| PCS propofol | Active Comparator | Patient-controlled sedation titrated by the patient to comfort level |
|
| midazolam and pethidine | Active Comparator | Midazolam and pethidine bolus doses administered by the investigator based on clinical parameters and observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol 10 MG/ML Injection | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time to Modified Observer's Assessment of Alertness and Sedation Scale (MOAAS) | Recovery of patient from sedation when MOAAS 5 is achieved | From time of arrival at the recovery area after completion of colonoscopy, until point of discharge from recovery area, assessed up to 2 hours post arrival at recovery |
| Recovery time to ambulation | Recovery of patient from sedation when patient starts ambulating | From time of arrival at the recovery area after completion of colonoscopy, until the point patient starts to ambulate, assessed up to 2 hours post arrival at recovery |
| Recovery time to discharge | Recovery of patient from sedation when patient is deemed fit for discharge home | From time of arrival at the recovery area after completion of colonoscopy, until the point patient is deemed fit for discharge home, assessed up to 2 hours post arrival at recovery |
| Endoscopist satisfaction score | After completion of colonoscopy, the endoscopist graded on a scale of 1 to 10, ease of the colonoscopy/procedure (1 = very difficult, 10 = very easy), and level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS). | After completion of colonoscopy, the endoscopist graded his satisfaction score from the start of colonoscopy, assessed until 2 hours after completion of colonoscopy |
| Patient satisfaction score | After completion of colonoscopy, the patient graded on a scale of 1 to 10, the level of satisfaction (1 = very dissatisfied, 10 = very satisfied) using a 10 cm visual analog scale (VAS). | Patient satisfaction score from start of sedation until point of discharge from recovery assessed until 3 hours from the start of sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue analgesic drug requirement | Requirement for rescue analgesic or sedative in addition to study drugs/sedatives, during the entire duration of colonoscopy | From start of sedation, and during the entire duration of colonoscopy, assessed up to 2 hours from the start of sedation |
| Total drug consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken to onset of sedation | Time taken for patient to reach a sedation score of MOAAS 3 or 4 | From start of sedation until MOAAS 3 or 4 attained, assessed up to one hour from the point sedation was commenced |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusat Perubatan Universiti Kebangsaan Malaysia | Cheras | Kuala Lumpur | 56000 | Malaysia |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D007267 | Injections |
| D008874 | Midazolam |
| D008614 | Meperidine |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Midazolam injection |
| Drug |
|
|
| Pethidine Hydrochloride 50 Mg/mL Solution for Injection | Drug |
|
|
| target controlled infusion pump | Device |
|
|
| patient-controlled sedation pump | Device |
|
|
| Patient willingness to repeat the same sedation technique | Patient responds yes or no. to willingness of having the same sedation during colonoscopy, in the future | From patient arrival to recovery post colonoscopy, area until the point of patient discharge, assessed up to 3 hours after arrival at recovery |
Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy |
| Total consumption of all study drugs from the start of sedation, during the entire duration of colonoscopy until completion of colonoscopy, assessed up to 2 hours from the start of sedation |
| Ease of colonoscopy score | endoscopist graded on a scale of 1 to 10, ease of procedure (1 = very difficult, 10 = very easy) | during the entire duration of colonoscopy from the start of colonoscopy, assessed up to 2 hours from the start of colonoscopy |
| Recalled events during colonoscopy | The number of recalled events during the entire duration of colonoscopy | Recalled events retrieved from patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery |
| Recalled discomfort/ pain during colonoscopy | The number of recalled events of discomfor/pain during the entire duration of colonoscopy | Recalled events of discomfort/pain retrived from the patient, from arrival to recovery area until point of discharge home, assessed up to 2 hours from arrival at recovery |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001569 | Benzodiazepines |
| 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 |
| D004364 | Pharmaceutical Preparations |