Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07000201
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-31
• Study Start: 2025-06-01
• Study First Posted: 2025-06-02
• Last Update Posted: 2025-06-05
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I patients will receive two capsules of pregabalin (Lyrica) 75 mg (total = 150 mg),	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),	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	One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;	-

Primary Outcome Measures

Name	Time	Method
Intraoperative sedation levels are assessed using the Ramsay Sedation Scale .	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.

Trial Locations

Locations (1)

Kasralaini medical school; 🇪🇬 Cairo, Giza, Egypt