ClinicalTrials.gg
Not yet recruitingNCT07000201Updated Jul 4, 2025

Preoperative Pregabalin vs Gabapentin in Elderly Undergoing Surgry,Controlled Trial

An interventional study of 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 Anxiety and Anxiety Disorder (Panic Disorder or GAD), sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.

Primary conditionPanic DisorderRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Panic Disorder
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Panic Disorder, a narrower term within Anxiety Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Cairo University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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

02

Conditions studied

  • Anxiety
  • Anxiety Disorder (Panic Disorder or GAD)

Browse trials for

03

In context

Panic Disorder Reclassified

270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.

This study's planned enrollment of 84 is close to the median of 77 across 215 interventional studies indexed under Panic Disorder.

Browse Panic Disorder studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Compared within Panic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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. (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
84 participants (estimated)

Study arms

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

    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;

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

    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;

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

    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

  • DrugOne 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.

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What researchers measure

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.

    Time frame: 1 hour after giving the drug

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Study locations

1 site
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2025; primary completion for Dec 2025, 3 months later.

Of 87 non-industry interventional studies with no phase under Panic Disorder, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's planned 3 months is below that.

Counting every sponsor, half of 87 studies reached it within 38 months; a quarter within 21 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2025
First posted
Jun 2, 2025
StartEst.
Sep 15, 2025
Primary completionEst.
Dec 15, 2025
CompletionEst.
Dec 30, 2025
Last update
Jul 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07000201
Lead sponsor
Cairo University
Responsible party
Marianne Magdy Youssef (Lecturer of anaesthesia ,icu & pain management, Cairo University) — Principal investigator
First posted
Jun 2, 2025
Start date
Sep 15, 2025 (estimated)
Primary completion
Dec 15, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jul 4, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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