Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study

NCT07184125 | Completed

• 1 other identifier: IRB-23-27
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Comparison of frequency of patient satisfaction & anxiety

  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.

  1 day

Study Arms (1)

1 group will be given Midazolam

2nd group will be given normal saline

Drug: To measure anxiolysis, satisfaction level of patient after receiving Midazolam

Interventions

To measure anxiolysis, satisfaction level of patient after receiving Midazolam DRUG

Anxiety \& satisfaction

1 group will be given Midazolam

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

124

You may qualify if:

• All patients undergoing breast conservation surgery
• ASA I-II

You may not qualify if:

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

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanam Cancer Memorial Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Dr. Mehwish Shafique, MBBS, FCPS Anesthesia

  Shaukat Khanam Cancer Memorial Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 01 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: August 30, 2024
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: January 8, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Till the end of study
• Access Criteria: All investigators, to help in analyzing the data.

Locations

PA (1)