Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;.
- Who it may be relevant to
- Registry conditions: Anxiety, Anxiety Disorder (Panic Disorder or GAD). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
the Sedative Efficacy of Preoperative Pregablin Versus Gabapentin in Elderly Undergoing Abdominopelvic Surgery : a Randomized Controlled Clinical Trial
Overview
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
- Drug One 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.
Primary outcome measures
- Intraoperative sedation levels are assessed using the Ramsay Sedation Scale . [Time frame: 1 hour after giving the drug]
Eligibility criteria
Inclusion Criteria:This study will include :
- geriatric patients, aged 65 years or older,
- Both sex,
- scheduled for elective abdominopelvic surgery with regional anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II.
Exclusion Criteria:We will exclude patients with any of the following:
- history of allergy to gabapentin or pregabalin;
- current use of gabapentin or pregabalin for other indications
- history of chronic pain or chronic daily use of analgesics; a
- history of epilepsy, other neurological disorders, cognitive impairment, or severe psychiatric disorders;
- severe cardiovascular or respiratory diseases;
- impaired renal function; and a history of drug or alcohol abuse.
- patients with anticipated prolonged duration of surgery for more than two hours
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Egypt · 1 center
- Kasralaini medical school — Cairo
Identifiers
NCT: NCT07000201 · N-70-2025