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Several studies have evaluated the efficacy of pregabalin in reducing preoperative anxiety, with inconsistent results. Similarly, inconclusive results have been reported regarding gabapentin and its effects in reducing preoperative anxiety. A previous study reported that a single dose of gabapentin or pregabalin administered 60 minutes before surgery in adults under general anesthesia was effective in reducing acute preoperative anxiety and elevated levels of sedation before and after surgery, with pregabalin having better anxiolytic and sedative effects than gabapentin. However, no previous studies have compared the efficacy of preoperative pregabalin or gabapentin as premedication to reduce intraoperative anxiety and induce sedation in geriatric patients undergoing major surgery with regional anesthesia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group I patients will receive two capsules of pregabalin (Lyrica) 75 mg (total = 150 mg), | Active Comparator |
| |
| group II patients will receive two capsules of gabapentin (Conventin) 300 mg (total = 600 mg), | Active Comparator |
| |
| group III patients will receive a matching placebo in the form of two capsules of powdered multivita | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water; | Drug | group I patients will receive two capsules of pregabalin (Lyrica) 75 mg (total = 150 mg), group II patients will receive two capsules of gabapentin (Conventin) 300 mg (total = 600 mg), and group III patients will receive a matching placebo in the form of two capsules of powdered multivitamin by mouth. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative sedation levels are assessed using the Ramsay Sedation Scale . | The Ramsay Sedation Score is a scale used to assess the level of sedation in patients. It ranges from 1 to 6, with higher scores indicating a deeper level of sedation score 1: Patient is anxious, agitated, or restless. Score 2: Patient is cooperative, oriented, and tranquil. Score 3: Patient responds to commands only. Score 4: Patient responds briskly to a light glabellar tap or loud auditory stimulus. Score 5: Patient responds sluggishly to a light glabellar tap or loud auditory stimulus. Score 6: Patient does not respond to pain. | 1 hour after giving the drug |
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Inclusion Criteria:This study will include :
Exclusion Criteria:We will exclude patients with any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasralaini medical school | Cairo | Giza Governorate | 12613 | Egypt |
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|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D016584 | Panic Disorder |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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