AnxietyNCT07000201
Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial
A study testing One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water; in people with Anxiety and Anxiety Disorder (Panic Disorder or GAD), run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxiety, Anxiety Disorder (Panic Disorder or GAD)
- What is being tested?
- One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Kasralaini medical school
Cairo, Giza Governorate, 12613
Kasralaini medical school Cairo university, 0201001551282, mora.magdy.mm@gmail.com
About this study
Official title: the Sedative Efficacy of Preoperative Pregablin Versus Gabapentin in Elderly Undergoing Abdominopelvic Surgery : a Randomized Controlled Clinical 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
- Conditions
- Anxiety, Anxiety Disorder (Panic Disorder or GAD)
- Being tested
- One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water;
- Medical subject headings
- Anxiety Disorders, Panic Disorder, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| group I patients will receive two capsules of pregabalin (Lyrica) 75 mg (total = 150 mg), | Active comparator | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: 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; |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after giving the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Magdy Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000201
- Sponsor's protocol ID
- N-70-2025
- Status last verified
- Jul 2025
- First submitted
- 23 May 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Sedative Efficacy of Preoperative Pregablin Versus Gabapentin in Elderly Undergoing Abdominopelvic Surgery : a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07000201
- Acronym / sponsor ID
- N-70-2025
- Conditions
- Anxiety, Anxiety Disorder (Panic Disorder or GAD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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; |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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.
- history of allergy to gabapentin or pregabalin;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | 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),, group III patients will receive a matching placebo in the form of two capsules of powdered multivita |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One hour prior to admission to the operating room, patients will receive the study medication (as premedication) by mouth with a sip of water; in people with Anxiety and Anxiety Disorder (Panic Disorder or GAD), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative sedation levels are assessed using the Ramsay Sedation Scale . (time frame: 1 hour after giving the drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.