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Efficacy of flupirtine in minimizing anxiety of patients scheduled for head surgery

Evaluating the role of Flupirtine for preoperative anxiety in patients undergoing craniotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007358
Enrollment
52
Registered
2016-10-13
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- Conscious, cooperative and oriented, brain tumor patients, aged 18-50 years of either sex, American society of Anaesthesiologists (ASA) physical status I-II

Interventions

Intervention1: Capsule Flupirtine 100 mg (F group): Total 5 sequential doses with a sip of water orally. Starting just after preoperative counselling (60 hours prior to surgery) and subsequently four

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Conscious, cooperative and oriented, brain tumor patients, aged 18-50 years of either sex, American society of Anaesthesiologists (ASA) physical status I-II, scheduled for elective craniotomy, in between August 2013 to July 2014.

Exclusion criteria

Exclusion criteria: history of psychiatric disease, end organ dysfunction, pregnancy, on antihypertensive, sedative, hypnotic, anxiolytic, analgesic or antidepressant medications, and history of drug allergy

Design outcomes

Primary

MeasureTime frame
Anxiety level [Visual analogue score (0-100)] on a 12-point questionnaireTimepoint: just before preoperative counselling (baseline), and 2 hours after the last dose of studied drug—

Secondary

MeasureTime frame
Patient characteristics affecting preoperative anxietyTimepoint: Before counselling;Patient demographicsTimepoint: Before counselling;Side effectsTimepoint: Throughout the period of observation—

Countries

India

Contacts

Public ContactGhanshyam Yadav

Institute of Medical Sciences, Banaras Hindu University

gauravhld@gmail.com8808631209

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026