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Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study

Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07184125
Enrollment
124
Registered
2025-09-19
Start date
2024-08-30
Completion date
2025-09-10
Last updated
2026-01-08

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

Conditions

Anxiety

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.

Detailed description

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.

Interventions

DRUGTo measure anxiolysis, satisfaction level of patient after receiving Midazolam

Anxiety & satisfaction

Sponsors

Shaukat Khanum Memorial Cancer Hospital & Research Centre
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of frequency of patient satisfaction & anxiety1 dayIt 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026