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A study to evaluate whether a drug, levetiracetam decreases anxiety associated with elective laparoscopic gall bladder surgery

Effect of pre-operative single dose Levetiracetam on anxiety associated with laparoscopic cholecystectomy: a randomized, double blinded, placebo controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/01/004323
Enrollment
102
Registered
2014-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patient with physical status ASA I and II, are scheduled for elective laparoscopic cholecystectomy

Interventions

Intervention1: Tablet levetiracetam 500mg: Levetiracetam is a nobel anti epileptic which also has anxiolysis and analgesic property.One 500 mg levetiracetam tablet will be given 4 hours before surger

Sponsors

Nazareth Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with physical status ASA I and II, are scheduled for elective laparoscopic cholecystectomy

Exclusion criteria

Exclusion criteria: 1. Age 70years 2. body mass index (BMI) 35 kg/m2 3. known sensitivity to study drugs 4. inability to tolerate oral medication and understand the anxiety (VAS) score, 5. has cardiac problem, renal or hepatic dysfunction, respiratory disease or any psychiatric problem. 6. on chronic pain medication, anticonvulsant or antidepressant. 7. pregnant patients 8. Patients are not giving consent to get enrolled in the study.

Design outcomes

Primary

MeasureTime frame
level of anxiety in terms of visual analogue score before surgeryTimepoint: level of anxiety in terms of visual analogue score will be assessed before giving the study drug, at pre operative holding area before entering to operation theater, at operation theater just before administering anaesthesia

Secondary

MeasureTime frame
sedation levelTimepoint: just before giving the study drug, at pre operative holding area before entering to operation theater, on operation theater table just before induction of anesthesia

Countries

India

Contacts

Public ContactSaurabh Kumar Das

Nazareth Hospital

drsauravdas1977@gmail.com8413031137

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 5, 2026