COMPARISON OF ORAL ALPRAZOLAM VERSUS ORAL CLONIDINE AND ORAL PREGABALIN AS PREANAESTHETIC MEDICATION IN LOWER LIMB SURGERIES

TO COMPARE THE EFFICACY AND SAFETY OF ORAL ALPRAZOLAM VERSUS ORAL CLONIDINE AND ORAL PREGABALIN AS PREANAESTHETIC MEDICATION IN PATIENTS UNDERGOING ELECTIVE LOWER LIMB SURGERIES

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032494

Enrollment

Registered

2021-04-01

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: G00-G99- Diseases of the nervous system

Interventions

Intervention1: ALPRAZOLAM: Alprazolam, short-acting benzodiazepine, the primary indication of this potent and intermediate duration of action is anxiety disorder. Its active metabolite has a short hal

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with age between 18-60 years of either gender. 2.Patients having grade I and grade II physical status according to ASA (American Society of Anesthesiologists). 3.Patients scheduled to undergo elective lower limb surgical procedure.

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating females. 2.Patients with chronic pain and psychiatric disease. 3.Patients with severe hepatic and renal disorders. 4.Patients refusal to participate in the study.

Design outcomes

Primary

Measure	Time frame
To study and compare the efficacy of oral alprazolam versus oral clonidine and oral pregabalin as a premedication for control of preoperative anxiety and sedation in patients undergoing elective lower limb surgeries.Timepoint: Anxiety and sedation will be observed just before giving the drug orally in the preoperative ward and just before going to operation theatre i.e. 2 hrs. after the drug administration.	—

Measure

Time frame

To study and compare the efficacy of oral alprazolam versus oral clonidine and oral pregabalin as a premedication for control of preoperative anxiety and sedation in patients undergoing elective lower limb surgeries.Timepoint: Anxiety and sedation will be observed just before giving the drug orally in the preoperative ward and just before going to operation theatre i.e. 2 hrs. after the drug administration.

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Secondary

Measure	Time frame
To compare safety in each group.Timepoint: Side effects due to drugs will be noted just before going to operation theatre i.e. 2 hrs. after the drug administration, after the completion of surgery and at 24 hrs.;To note the patientâ??s satisfaction in each group.Timepoint: Patient satisfaction about the preanasethetic medication will be noted at 24 hrs.;To study and compare effects on the psychomotor functions by oral alprazolam versus oral clonidine and oral pregabalin in patients undergoing elective lower limb surgeries.Timepoint: Psychomotor functions will be observed just before giving the drug orally in the preoperative ward and just before going to operation theatre i.e. 2 hrs. after the drug administration.;To study and compare the effects on haemodynamic parameters by oral alprazolam versus oral clonidine and oral pregabalin in patients undergoing elective lower limb surgeries.Timepoint: Haemodynamic parameters (Heart rate, systolic BP,diastolic BP and respiratory rate) will be observed just before giving the drug orally in the preoperative ward, just before going to operation theatre i.e. 2hrs after drug administration, after completion of surgery & after 24 hours.	—

Measure

Time frame

To compare safety in each group.Timepoint: Side effects due to drugs will be noted just before going to operation theatre i.e. 2 hrs. after the drug administration, after the completion of surgery and at 24 hrs.;To note the patientâ??s satisfaction in each group.Timepoint: Patient satisfaction about the preanasethetic medication will be noted at 24 hrs.;To study and compare effects on the psychomotor functions by oral alprazolam versus oral clonidine and oral pregabalin in patients undergoing elective lower limb surgeries.Timepoint: Psychomotor functions will be observed just before giving the drug orally in the preoperative ward and just before going to operation theatre i.e. 2 hrs. after the drug administration.;To study and compare the effects on haemodynamic parameters by oral alprazolam versus oral clonidine and oral pregabalin in patients undergoing elective lower limb surgeries.Timepoint: Haemodynamic parameters (Heart rate, systolic BP,diastolic BP and respiratory rate) will be observed just before giving the drug orally in the preoperative ward, just before going to operation theatre i.e. 2hrs after drug administration, after completion of surgery & after 24 hours.

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Countries

India

Contacts

Public ContactDr Mohd Fazal Ahmed Makki

Bhagat Phool Singh Government Medical College For Women

seema17march@gmail.com9466359666

Outcome results

None listed

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