Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study

NCT ID: NCT07184125

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-30

Study Completion Date

2025-09-10

Brief Summary

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Patient are randomized into 2 groups under computer registered numbers. Patient anxiety score is calculated through APAIS SCORE. Then one group is given Midazolam, and the other group is given normal saline and then after one day patients satisfaction is calculated through Lppsq scale.

Detailed Description

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Patient are randomized into 2 groups under computer registered numbers. After taking approval from hospital ethical committee, 124 females fulfilling inclusion criteria are selected. All patients will receive written information about the study on the day before surgery and before signing informed consent. Patient anxiety score is calculated through APAIS SCORE. Then one group is given Midazolam, and the other group is given normal saline and then after one day patients satisfaction is calculated through Lppsq scale.

Conditions

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Anxiety

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1 group will be given Midazolam

2nd group will be given normal saline

To measure anxiolysis, satisfaction level of patient after receiving Midazolam

Intervention Type DRUG

Anxiety \& satisfaction

Interventions

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To measure anxiolysis, satisfaction level of patient after receiving Midazolam

Anxiety \& satisfaction

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. All patients undergoing breast conservation surgery
2. ASA I-II

Exclusion Criteria

1. Patients already on anxiolytic medication
2. Pregnancy
3. Allergy to Midazolam,
4. Patient with diagnosed psychosis,
5. Chronic kidney disease.
Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaukat Khanum Memorial Cancer Hospital & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Mehwish Shafique, MBBS, FCPS Anesthesia

Role: PRINCIPAL_INVESTIGATOR

Shaukat Khanam Cancer Memorial Hospital & Research Centre

Locations

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Shaukat Khanam Cancer Memorial Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB-23-27

Identifier Type: -

Identifier Source: org_study_id

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