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| Name | Class |
|---|---|
| Norhan Abdel Aleem Ali | UNKNOWN |
| Hagar Hassanein Refaee | UNKNOWN |
| Ahmed Abdullah Fathi Mohamed Almadawi | UNKNOWN |
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To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ● Group P1 (N 15) | Active Comparator | Patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml). |
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| ● Group P2 (N 15) | Active Comparator | Patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml). |
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| ● Group P3 (N 15) | Active Comparator | patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocaine 2% (1.5 ml) and 25 ug fentany | Drug | Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of motor Block in hours | The primary outcome measure will be duration of motor Block in minutes, defined as the duration between intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block). | Through Study Completion,an average of 1day |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of sensory block in minutes | Onset of sensory block, defined as the duration between intrathecal drug injection and complete absence of skin sensation to the pinprick test at T10 dermatome level in minutes. | Through Study Completion,an average of 1day |
| Onset of motor block in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Abdalla Mohamed | Cairo | 11451 | Egypt |
Till Study Ending
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The purpose of this study is to determine the least sufficient dose of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg required for day-case lower abdominal and urologic surgeries , fewer adverse effects, faster recovery time, and shorter stay in post anesthesia care unit (PACU) in the geriatric patient population, as a previous study has investigated hyperbaric prilocaine (30 mg) when combined with fentanyl (20 µg) for a day-case perianal surgery, achieving a spinal anaesthesia with a mean sensory level of T9
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Patients will be randomly allocated to one of the 3 groups by sealed closed envelop technique
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Onset of motor block, defined as the duration between intrathecal drug injection and reaching a Bromage's score ≥ 2 in minutes. |
| Through Study Completion,an average of 1day |
| Highest dermatomal level of sensory block. | Highest dermatomal level of sensory block. | Through Study Completion,an average of 1day |
| Time to reach to highest sensory block in minutes. | Time to reach to highest sensory block in minutes. | Through study completion,an average of 1day |
| Motor block at the time of reaching highest sensory block. | Motor block at the time of reaching highest sensory block. | through study completion,an average of 1day |
| Full regression of sensory block | Full regression of sensory block, defined as the duration between intrathecal drug injection and regression to the S2 dermatome in minutes. | Through Study Completion,an average of 1day |
| Duration of PACU stay | Duration of Post Anesthesia Care Unit stay in minutes. | Through Study Completion,an average of 1day |
| The incidence of adverse effects | The incidence of adverse effects like hypotension, bradycardia, apnea, nausea, shivering, pruritus, block failure and pain during the operation. Failure to achieve a block level of T10 or additional analgesia request will be considered as block failure. Hypotension will be defined as a systolic blood pressure of < 90 mmHg or a decrease in mean arterial pressure of more than 20% from baseline preoperative value and bradycardia will be defined as heart rate < 50 beat/min. | Through Study Completion,an average of 1day |