Anxiety, Anxiety Disorder (Panic Disorder or GAD)
Conditions
Brief summary
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
Interventions
DRUGOne hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study will include : 1. geriatric patients, aged 65 years or older, 2. Both sex, 3. scheduled for elective abdominopelvic surgery with regional anesthesia 4. American Society of Anesthesiologists (ASA) physical status I or II.
Exclusion criteria
We will exclude patients with any of the following: 1. history of allergy to gabapentin or pregabalin; 2. current use of gabapentin or pregabalin for other indications 3. history of chronic pain or chronic daily use of analgesics; a 4. history of epilepsy, other neurological disorders, cognitive impairment, or severe psychiatric disorders; 5. severe cardiovascular or respiratory diseases; 6. impaired renal function; and a history of drug or alcohol abuse. 7. patients with anticipated prolonged duration of surgery for more than two hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative sedation levels are assessed using the Ramsay Sedation Scale . | 1 hour after giving the drug | 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. |
Countries
Egypt
Outcome results
None listed