Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial

ConditionsAnxiety Anxiety Disorder (Panic Disorder or GAD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

84 Participants

are divided into 3 treatment groups

Group A: group I patients will receive two capsules of pregabalin (Lyrica) 75 mg (total = 150 mg),Active comparator 1 intervention

Group B: group II patients will receive two capsules of gabapentin (Conventin) 300 mg (total = 600 mg),Active comparator 1 intervention

Group C: group III patients will receive a matching placebo in the form of two capsules of powdered multivitaPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

1 hour after giving the drug

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Kasralaini medical school Status unavailable 12613, Cairo, Giza Governorate Egypt

Egypt

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

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