Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial

Cairo University (CU)

Status: Not yet enrolling

Conditions: Anxiety; Anxiety Disorder (Panic Disorder or GAD)

Treatments: 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;

Study type: Interventional

Funder types: Other

Identifiers

NCT07000201

N-70-2025

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 3 patient groups, including a placebo group

group I patients will receive two capsules of pregabalin (Lyrica) 75 mg (total = 150 mg),

Active Comparator group

Treatment:

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 II patients will receive two capsules of gabapentin (Conventin) 300 mg (total = 600 mg),

Active Comparator group

Treatment:

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 III patients will receive a matching placebo in the form of two capsules of powdered multivita

Placebo Comparator group

Treatment:

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;