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A comparative study comparing anxiety reducing effect of tablet Lorazepam and tablet Alprazolam.

A prospective randomized double blinded comparison of the effect of tablet Lorazepam(1mg) and tablet Alprazolam(0.5mg) administered as oral premedication 3 hours prior to general anesthesia in patients undergoing elective laparoscopic cholecystectomy. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066874
Enrollment
200
Registered
2024-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: K829- Disease of gallbladder, unspecified

Interventions

Intervention1: ALPRAZOLAM Dose-0.5mg, Frequency- single tablet 3 hours prior to surgery. Route- Oral Time duration - 12 months: Anxiety level, amnesia and degree of sedation will recorded at the tim

Sponsors

Sanjay Gandhi Post Graduate Institute of Medical sciences Lucknow Uttar pradesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient giving written consent. 2. Patients belonging to ASA grade I and II. 3. All genders 4. Normal BMI(18.5-25) subjects. 5. Patients in the age group (18-60years) undergoing elective laparoscopic cholecystectomy.

Exclusion criteria

Exclusion criteria: 1. Patients not giving consent. 2. ASA grade III and IV. 3. Emergency surgeries. 4. Patient who had taken analgesic, sedative, antidepressant, and on antiepileptic drugs were excluded. 6. Patients with psychiatry illness will be excluded. 5. Patients with anticipated difficult airway.

Design outcomes

Primary

MeasureTime frame
Primary Objective – 1.Comparison of Alprazolam and Lorazepam in terms of anxiolysis by Hamilton anxiety rating scale (HAM-A). 2. Comparison of level of amnesia by MMSE score at time T1 and T2. Timepoint: At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2)

Secondary

MeasureTime frame
Secondary objectives – (i)Comparison of level of sedation by using Ramsey sedation score at time T1 & T2Timepoint: At the time of giving premedication in the ward 3 hours prior to GA (T1), in the preoperative ward before shifting the patient to the operation theatre (T2)

Countries

India

Contacts

Public ContactDr Vipiendra Singh Solanki

Sanjay Gandhi Post Graduate Institute of Medical sciences, Lucknow, Uttar pradesh.

Cardarone@gmail.com8871062490

Outcome results

None listed

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