AnxietyNCT07184125
Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study
An observational study of Anxiety, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- To measure anxiolysis, satisfaction level of patient after receiving Midazolam
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2024to 10 Sep 2025
- How long will I take part?
- 01 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 124
Who may be able to join
- All patients undergoing breast conservation surgery
- ASA I-II
Who cannot join
- Patients already on anxiolytic medication
- Pregnancy
- Allergy to Midazolam,
- Patient with diagnosed psychosis,
- Chronic kidney disease.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanam Cancer Memorial Hospital Lahore
Lahore, Punjab Province, 54000
About this 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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- To measure anxiolysis, satisfaction level of patient after receiving Midazolam
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To measure anxiolysis, satisfaction level of patient after receiving MidazolamDrug
Anxiety \& satisfaction
| Study group | Role | What they receive |
|---|---|---|
| 1 group will be given Midazolam | 2nd group will be given normal saline Receives: Drug: To measure anxiolysis, satisfaction level of patient after receiving Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start30 Aug 2024
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
- Target duration
- 01 Days
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Mehwish Shafique, MBBS, FCPS Anesthesia, Principal investigator, Shaukat Khanam Cancer Memorial Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184125
- Sponsor's protocol ID
- IRB-23-27
- Status last verified
- Aug 2024
- First submitted
- 13 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dr. Ahsun Waqar, Dr. Saad Ur Rehman, Dr. Huma Saleem
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Midazolam as Premedication in Patients Undergoing Breast Conservation Study
- ClinicalTrials.gov ID
- NCT07184125
- Acronym / sponsor ID
- IRB-23-27
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 01 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group will be given Midazolam | – | Drug: To measure anxiolysis, satisfaction level of patient after receiving Midazolam2nd group will be given normal saline |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 124
Key inclusion criteria (2 listed)
- All patients undergoing breast conservation surgery
- ASA I-II
Key exclusion criteria (5 listed)
- Patients already on anxiolytic medication
- Pregnancy
- Allergy to Midazolam,
- Patient with diagnosed psychosis,
- Chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To measure anxiolysis, satisfaction level of patient after receiving MidazolamAnxiety \& satisfaction | Drug | 1 group will be given Midazolam |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Yes. Dr. Ahsun Waqar, Dr. Saad Ur Rehman, Dr. Huma Saleem
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mehwish Shafique, MBBS, FCPS Anesthesia principal investigator
Shaukat Khanam Cancer Memorial Hospital & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of frequency of patient satisfaction & anxiety (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.