Female Patients Under the Age of 65 Who Will Undergo Breast Cancer SurgeryNCT05647642
The Effect of Premedication on Postoperative Pain and Anxiety in Breast Cancer Surgery
An observational study of Female Patients Under the Age of 65 Who Will Undergo Breast Cancer Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Patients Under the Age of 65 Who Will Undergo Breast Cancer Surgery
- What is being tested?
- Precedex and dormicum
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2022to 30 Jan 2023
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA 1-2-3, female patients aged 18-65 who will undergo breast cancer surgery
Who may be able to join
- ASA 1-2-3
- 18-65 aged
- Female patients
Who cannot join
- Under 18 years old and over 65 years old
- Having a history of cerebrovascular disease illiteracy
- Have visual and auditory problems İnability to cooperate with cognitive function test
- Having emergency surgery
- Those who are unable to read, understand and sign the consent form
- Patients deemed unsuitable by the investigator
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
AbdurrahmanYAOTRH
Ankara
Abdurrahman Yurtaslan Onkoloji Training and Research Hospital
About this study
Official title: The Effect of Premedication Methods to be Applied to Prevent Preoperative Anxiety in Patients Who Will be Operated for Breast Cancer, on Postoperative Anxiety and Pain
In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery.
Read the detailed description
In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery. The STAI-1(State Trait Anxiety İnventory ) form and APAIS (Amsterdam Preoperative Anxiety and İnformation Scale) scale were filled in for all preoperative patients. Afterwards, the patients were treated with either midazolam or dexmedetothymidine, depending on the anesthesiologist's preference. After administration, he was taken to surgery. As intraoperative analgesics, 2 mg/kg tramadol and 15 mg/kg paracetamol were administered to all patients. postoperative recovery time (aldrete 10), 1., 2.,6.,12.,24. VAS score, postoperative nausea-vomiting scale, STAI-1(State Trait Anxiety İnventory ) form, first need time if postoperative analgesic was needed, and 24-hour total analgesic consumption were recorded. It was aimed to examine the effects of different premedications on postoperative pain and anxiety
- Being tested
- Precedex and dormicum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precedex and dormicumDrug
Premedication
| Study group | Role | What they receive |
|---|---|---|
| low dose midazolam | 0,025 mg/kg Midazolam Receives: Drug: Precedex and dormicum | |
| high dose midazolam | 0,05 mg/kg Midazolam Receives: Drug: Precedex and dormicum | |
| low dose dexmedetothymidine | 0.5 mg/kg dexmedetothymidine 10 minute infusion Receives: Drug: Precedex and dormicum | |
| high dose dexmedetothymidine | 1mg/kg dexmedetothymidine 10 minute infusion Receives: Drug: Precedex and dormicum |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of premedication on postoperative pain and anxiety scores
Measured: November 2022-December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start16 Oct 2022
- Primary completion28 Nov 2022
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Patients Under the Age of 65 Who Will Undergo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda ARI, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647642
- Sponsor's protocol ID
- 2022-09/2057
- Status last verified
- Dec 2022
- First submitted
- 3 Dec 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Premedication Methods to be Applied to Prevent Preoperative Anxiety in Patients Who Will be Operated for Breast Cancer, on Postoperative Anxiety and Pain
- ClinicalTrials.gov ID
- NCT05647642
- Acronym / sponsor ID
- 2022-09/2057
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 12 Dec 2022 (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.
In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery.
Detailed description
In this study, it was investigated whether the premedication drug administered before the surgery had an effect on postoperative pain and anxiety scores in female patients under the age of 65 who will undergo breast cancer surgery. The STAI-1(State Trait Anxiety İnventory ) form and APAIS (Amsterdam Preoperative Anxiety and İnformation Scale) scale were filled in for all preoperative patients. Afterwards, the patients were treated with either midazolam or dexmedetothymidine, depending on the anesthesiologist's preference. After administration, he was taken to surgery. As intraoperative analgesics, 2 mg/kg tramadol and 15 mg/kg paracetamol were administered to all patients. postoperative recovery time (aldrete 10), 1., 2.,6.,12.,24. VAS score, postoperative nausea-vomiting scale, STAI-1(State Trait Anxiety İnventory ) form, first need time if postoperative analgesic was needed, and 24-hour total analgesic consumption were recorded. It was aimed to examine the effects of different premedications on postoperative pain and anxiety
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low dose midazolam | – | Drug: Precedex and dormicum0,025 mg/kg Midazolam |
| high dose midazolam | – | Drug: Precedex and dormicum0,05 mg/kg Midazolam |
| low dose dexmedetothymidine | – | Drug: Precedex and dormicum0.5 mg/kg dexmedetothymidine 10 minute infusion |
| high dose dexmedetothymidine | – | Drug: Precedex and dormicum1mg/kg dexmedetothymidine 10 minute infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1-2-3, female patients aged 18-65 who will undergo breast cancer surgery
Key inclusion criteria (3 listed)
- ASA 1-2-3
- 18-65 aged
- Female patients
Key exclusion criteria (6 listed)
- Under 18 years old and over 65 years old
- Having a history of cerebrovascular disease illiteracy
- Have visual and auditory problems İnability to cooperate with cognitive function test
- Having emergency surgery
- Those who are unable to read, understand and sign the consent form
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 |
|---|---|---|
| Precedex and dormicumPremedication | Drug | high dose dexmedetothymidine, high dose midazolam, low dose dexmedetothymidine, low dose midazolam |
Primary outcome
effect of premedication on postoperative pain and anxiety scores
Time frame: November 2022-December 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: 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.
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 Female Patients Under the Age of 65 Who Will Undergo Breast Cancer Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda ARİ (+905382598442, seyda93.ari@yandex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of premedication on postoperative pain and anxiety scores (time frame: November 2022-December 2022). 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 12 Dec 2022.