Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

Up to 60 year

Sex eligibility

Female

Study type

Observational

Primary location

Shaukat Khanam Cancer Memorial Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients undergoing breast conservation surgery
ASA I-II

Exclusion criteria

Patients already on anxiolytic medication
Pregnancy
Allergy to Midazolam,
Patient with diagnosed psychosis,
Chronic kidney disease.

Treatment and study plan

To measure anxiolysis, satisfaction level of patient after receiving Midazolam

Drug

Anxiety & satisfaction

Primary outcomes

Comparison of frequency of patient satisfaction & anxiety

Time frame: 1 day

It is a single blinded randomized control trial 124 adult females scheduled for surgery, were randomized to receive either Intravenous Midazolam or single Placebo before anesthesia induction. Pre and post medication anxiety levels on day of surgery will be assessed on APAIS score. Post operative satisfaction will be assessed on first post operative day using Lppsq.

Sponsors and collaborators

Lead sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 19, 2025
Registry last updated: Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed