Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial

NCT ID: NCT07000201

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-12-30

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

Conditions

Anxiety; Anxiety Disorder (Panic Disorder or GAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marianne Magdy Youssef

Lecturer of anaesthesia ,icu & pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasralaini medical school

Cairo, Giza Governorate, Egypt

Countries

Egypt

Facility Contacts

Kasralaini medical school Cairo university

Role: primary

mora.magdy.mm@gmail.com

0201001551282

Other Identifiers

N-70-2025

Identifier Type: -

Identifier Source: org_study_id