Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled 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

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Key information

Conditions

Anxiety Anxiety Disorder (Panic Disorder or GAD) Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Panic Disorder

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasralaini medical school

Cairo, Giza Governorate, 12613, Egypt

Location contact

Kasralaini medical school Cairo university

CONTACT

[email protected]

0201001551282

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Intraoperative sedation levels are assessed using the Ramsay Sedation Scale .

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

the Sedative Efficacy of Preoperative Pregablin Versus Gabapentin in Elderly Undergoing Abdominopelvic Surgery : a Randomized Controlled Clinical Trial

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jun 2, 2025
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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