Total Anesthetic ConsumptionNCT06477731
Waiting Time in the Premedication Room on Anxiety
An observational study of Total Anesthetic Consumption, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Anesthetic Consumption
- What is being tested?
- total anesthetic consumption
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 30 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 130 patients over the age of 18 who will receive general anesthesia and undergo surgical procedures will be included in the study.
Who may be able to join
- Being in the age group of 18 and over
- Being literate and able to communicate
- Individuals will have surgery in ENT, Urology, Brain Surgery, Orthopedics, General Surgery, Plastic Surgery, CVS and gynecology and obstetrics departments.
- Agreeing to participate in the research voluntarily
Who cannot join
- alcohol or drug use
- history of psychiatric illness
- central nervous system disease
- use of psychotropic medication
- pregnancy
- lack of vision, hearing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: The Effect of Waiting Time in the Premedication Room on Anxiety and Intraoperative Anesthetic Need
The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.
- Conditions
- Total Anesthetic Consumption
- Being tested
- total anesthetic consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total anesthetic consumptionBehavioural
total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.
What is being measured
The primary outcome is the main question the study is designed to answer.
total anesthetic consumption
The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start20 Jun 2024
- Primary completion25 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Anesthetic ConsumptionStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477731
- Sponsor's protocol ID
- istinye erkan
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayrak A, Sagiroglu G, Copuroglu E. Effects of Preoperative Anxiety on Intraoperative Hemodynamics and Postoperative Pain. J Coll Physicians Surg Pak. 2019 Sep;29(9):868-873. doi: 10.29271/jcpsp.2019.09.868.
PubMed 31455484Ahmetovic-Djug J, Hasukic S, Djug H, Hasukic B, Jahic A. Impact of Preoperative Anxiety in Patients on Hemodynamic Changes and a Dose of Anesthetic During Induction of Anesthesia. Med Arch. 2017 Oct;71(5):330-333. doi: 10.5455/medarh.2017.71.330-333.
PubMed 29284900Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
PubMed 10589606
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Waiting Time in the Premedication Room on Anxiety and Intraoperative Anesthetic Need
- ClinicalTrials.gov ID
- NCT06477731
- Acronym / sponsor ID
- istinye erkan
- Conditions
- Total Anesthetic Consumption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 25 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 27 Jun 2024 (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.
The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 130 patients over the age of 18 who will receive general anesthesia and undergo surgical procedures will be included in the study.
Key inclusion criteria (4 listed)
- Being in the age group of 18 and over
- Being literate and able to communicate
- Individuals will have surgery in ENT, Urology, Brain Surgery, Orthopedics, General Surgery, Plastic Surgery, CVS and gynecology and obstetrics departments.
- Agreeing to participate in the research voluntarily
Key exclusion criteria (6 listed)
- alcohol or drug use
- history of psychiatric illness
- central nervous system disease
- use of psychotropic medication
- pregnancy
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 |
|---|---|---|
| total anesthetic consumptiontotal anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety. | Behavioural | – |
Primary outcome
total anesthetic consumption
Time frame: 1 month
The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 31455484Bayrak A, Sagiroglu G, Copuroglu E. Effects of Preoperative Anxiety on Intraoperative Hemodynamics and Postoperative Pain. J Coll Physicians Surg Pak. 2019 Sep;29(9):868-873. doi: 10.29271/jcpsp.2019.09.868.
- Results publication: PubMed 29284900Ahmetovic-Djug J, Hasukic S, Djug H, Hasukic B, Jahic A. Impact of Preoperative Anxiety in Patients on Hemodynamic Changes and a Dose of Anesthetic During Induction of Anesthesia. Med Arch. 2017 Oct;71(5):330-333. doi: 10.5455/medarh.2017.71.330-333.
- Results publication: PubMed 10589606Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Total Anesthetic Consumption, run by Istinye University 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 4 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 27 Jun 2024. 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?
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?
total anesthetic consumption (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06477731, which also lists 3 linked publications.
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 27 Jun 2024.