Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial

NCT07000201 | Not Yet Recruiting

• 1 other identifier: N-70-2025
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour after giving the drug

Study Arms (3)

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

ACTIVE COMPARATOR

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

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

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;

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralaini medical school

Cairo, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders; Panic Disorder; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia ,icu & pain management

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 2, 2025
• Study Start: September 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

EG (1)