Post Anesthesia Discharge Time in Patients of Breast Cancer SurgeryNCT07180810
Effect of Dexmedetomidine Infusion on Post Anesthesia Discharge Time
A study testing Dexmedetomidine infusion low dose and Group B receiving normal saline in people with Post Anesthesia Discharge Time in Patients of Breast Cancer Surgery, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
A randomised control trial evaluating the effect of low dose dexmedetomidine infusion on post anesthesia discharge time in patients of day case breast cancer surgery compared with placebo infusion. The primary outcome was to compare the frequency of early discharge in each group. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Post Anesthesia Discharge Time in Patients of Breast Cancer Surgery
- What is being tested?
- Dexmedetomidine infusion low dose and Group B receiving normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Sep 2023to 20 Aug 2025
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 yrs, ASA 1 and 2, elective breast cancer surgery
Who cannot join
- BMI greater than 35, CKD stage 3 or greater, known drug allergy to study drug, bradycardia, history of PONV, patients on antiepileptics
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanum Memorial Cancer Hospital and Research Centre
Lahore, Pubjab, 54782
About this study
Official title: Effect of Low Dose Intravenous Dexmedetomidine on Post Anesthesia Discharge After Day Case Breast Cancer Surgery
A randomised control trial evaluating the effect of low dose dexmedetomidine infusion on post anesthesia discharge time in patients of day case breast cancer surgery compared with placebo infusion. The primary outcome was to compare the frequency of early discharge in each group.
Read the detailed description
A prospective Randomised control trial evaluating the effect of low dose dexmedetomidine infusion on post anesthesia discharge time in patients of day case breast cancer surgery compared with placebo infusion. The primary outcome was to compare the frequency of early discharge in each group. Early discharge was defined as within two hours. The sample size was of 82 female patients with a specific inclusion and exclusion criteria. Randomisation was done through computer software and the trial was double blinded. SPSS version 22 will be used for data analysis.
- Being tested
- Dexmedetomidine infusion low dose, Group B receiving normal saline
- Keywords
- Breast cancer surgery, Dexmedetomidine, Post anesthesia discharge time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusion low doseDrug
low dose dexmedetomidine infusion at rate 0.6mcg/kg/hour rate .
Group B receiving normal salineDrug
Normal saline infusion at rate 0.6mcg/kr/hour rate
| Study group | Role | What they receive |
|---|---|---|
| Group A, receiving low dose dexmedetomidine infusion | Experimental | Group A, receiving low dose dexmedetomidine infusion at 0.6mcg/kg/hour rate Receives: Drug: Dexmedetomidine infusion low dose |
| Group B, receiving normal saline infusion as placebo | Placebo comparator | normal saline being used as placebo at rate 0.6mch/kg/hour rate Receives: Drug: Group B receiving normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of early discharge
post anesthesia discharge time within 2 hours
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start5 Sep 2023
- Primary completion20 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Anesthesia Discharge Time in Patients of Breast Cancer SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A being administered low dose intravenous dexmedetomidine infusion vs Group B being admissions IV normal saline infusion at rate 0.6mcg/kg/hour rate
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Almas nil Iqbal, FRCA, Study chair, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180810
- Sponsor's protocol ID
- IRB-23-14
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dose Intravenous Dexmedetomidine on Post Anesthesia Discharge After Day Case Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07180810
- Acronym / sponsor ID
- IRB-23-14
- Keywords
- Breast cancer surgery, Dexmedetomidine, Post anesthesia discharge time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 18 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.
A randomised control trial evaluating the effect of low dose dexmedetomidine infusion on post anesthesia discharge time in patients of day case breast cancer surgery compared with placebo infusion. The primary outcome was to compare the frequency of early discharge in each group.
Detailed description
A prospective Randomised control trial evaluating the effect of low dose dexmedetomidine infusion on post anesthesia discharge time in patients of day case breast cancer surgery compared with placebo infusion. The primary outcome was to compare the frequency of early discharge in each group. Early discharge was defined as within two hours. The sample size was of 82 female patients with a specific inclusion and exclusion criteria. Randomisation was done through computer software and the trial was double blinded. SPSS version 22 will be used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Group A being administered low dose intravenous dexmedetomidine infusion vs Group B being admissions IV normal saline infusion at rate 0.6mcg/kg/hour rate
| Arm | Type | Receives |
|---|---|---|
| Group A, receiving low dose dexmedetomidine infusion | Experimental | Drug: Dexmedetomidine infusion low doseGroup A, receiving low dose dexmedetomidine infusion at 0.6mcg/kg/hour rate |
| Group B, receiving normal saline infusion as placebo | Placebo comparator | Drug: Group B receiving normal salinenormal saline being used as placebo at rate 0.6mch/kg/hour rate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-60 yrs, ASA 1 and 2, elective breast cancer surgery
Key exclusion criteria (1 listed)
- BMI greater than 35, CKD stage 3 or greater, known drug allergy to study drug, bradycardia, history of PONV, patients on antiepileptics
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 |
|---|---|---|
| Dexmedetomidine infusion low doselow dose dexmedetomidine infusion at rate 0.6mcg/kg/hour rate . | Drug | Group A, receiving low dose dexmedetomidine infusion |
| Group B receiving normal salineNormal saline infusion at rate 0.6mcg/kr/hour rate | Drug | Group B, receiving normal saline infusion as placebo |
Primary outcome
Frequency of early discharge
Time frame: 120 minutes
post anesthesia discharge time within 2 hours
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 23 Sep 2025.
- Reference study from which sample size was calculatedLink provided by the sponsor.
- Individual participant dataSharing planned: No. undecided
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.
Almas nil Iqbal, FRCA study chair
Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine infusion low dose and Group B receiving normal saline in people with Post Anesthesia Discharge Time in Patients of Breast Cancer Surgery, 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 1 inclusion and 1 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 23 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Frequency of early discharge (time frame: 120 minutes). 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 23 Sep 2025.