- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690764
Evaluation of the Effects of Preoperative Anxiety in Patients Undergoing Total Intravenous Anesthesia (TIVA)
Evaluation of the Effects of Preoperative Anxiety on Hemodynamics, Recovery and Drug Consumption in Patients Undergoing Total Intravenous Anesthesia (TIVA) for Neuromuscular Monitoring.
Study Overview
Status
Detailed Description
Introduction: Preoperative anxiety has been reported in 60-80% of the patients who will undergo surgery. Preoperative anxiety and fear may be due to the type of anesthesia, as well as to the patient's previous experiences, personality traits, concerns about surgical intervention, and postoperative pain. The anxiety levels of the patients can be affected by various factors such as their previous experiences, the way they come to the hospital, their gender, age, and the type of surgery they will undergo. The most widely used medical test for anxiety measurement is the State-Trait Anxiety Inventory (STAI) scale developed by Spielberg et al.
Objective: The primary aim of our study is to evaluate the effects of preoperative anxiety on intraoperative hemodynamics and recovery, and the secondary aim is to determine its effect on intraoperative drug consumption.
Hypothesis: Our hypothesis is that preoperative anxiety levels affect intraoperative hemodynamics and recovery and affect intraoperative drug consumption.
Materials and Methods: The study was planned prospectively, observationally. In the neurosurgery operating room of Sultan Abdülhamit Han Training and Research Hospital, patients whose operation is planned to be performed under neuromonitoring between 1 September 2019 and 1 February 2021 will receive a preoperative Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scores will be recorded. Afterward, routine anesthesia induction and follow-up will be performed for patients who are taken to the operating table. The preoperative anxiety score will be compared with the data recorded after the operation (hemodynamic data, total drug amount, recovery time).
Inclusion Criteria: Patients undergoing TIVA (Total Intravenous Anesthesia) due to Neuromuscular monitoring during neurosurgery operation, aged 18-70, who are literate, who do not have any psychiatric and neurological diseases, who are in ASA I and II class, Patients who do not drink alcohol regularly will be included in the study.
Exclusion Criteria: Patients who do not agree to participate in the study, patients who can not cooperate, patients using psychiatric drugs regularly and patients with chronic drug habits will be excluded from the study.
Study population: 80 patients
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Bülent B güven, MD
- Phone Number: 05336383445
- Email: barguv@gmail.com
Study Contact Backup
- Name: Ayşın ERSOY, MD
- Phone Number: 0505 7546063
- Email: drersoy71@hotmail.com
Study Locations
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Istanbul, Turkey, 34668
- Recruiting
- Bülent Barış güven
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Contact:
- Bülent B güven, MD
- Phone Number: 05336383445
- Email: barguv@gmail.com
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Principal Investigator:
- Ayşın ERSOY, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing TIVA (Total Intravenous Anesthesia) due to Neuromuscular monitoring during neurosurgery operation, aged 18-70, who are literate, who do not have any psychiatric and neurological diseases, who are in ASA I and II class, Patients who do not drink alcohol regularly will be included in the study.
Exclusion Criteria:
- Patients who do not agree to participate in the study, patients who can not cooperate, patients using psychiatric drugs regularly and patients with chronic drug habits will be excluded from the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scores
Time Frame: Pre-surgery baseline to 1 week of postoperation
|
STAI measures anxiety.
The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so).
Scores range from 20-80 and the higher the score the greater the anxiety level.
|
Pre-surgery baseline to 1 week of postoperation
|
Total intraoperative opioid consumption
Time Frame: During the neurological surgery
|
The cumulative remifentanyl (microgram / kilogram) consumption after surgery will be recorded.
|
During the neurological surgery
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Total intraoperative propofol consumption
Time Frame: During the neurological surgery
|
The cumulative propofol (miligram / kilogram) consumption after surgery will be recorded.
|
During the neurological surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean blood pressure change
Time Frame: within 5 minutes after surgical incision
|
The maximal mean blood pressure within the first 5 minutes after surgical incision will be recorded. The mean blood pressure change from baseline will be calculated. The unit is mmHg. |
within 5 minutes after surgical incision
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Heart rate change
Time Frame: within 5 minutes after surgical incision
|
The maximal heart rate within the first 5 minutes after surgical incision will be recorded. The heart rate change from baseline level will be calculated. The unit is beats per minute. |
within 5 minutes after surgical incision
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Lowest oxygen saturation
Time Frame: Time between neuromuscular blockade and 20 minutes after completion of endotracheal extubation
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Lowest oxygen saturation will be recorded and values under 95 percent will be considered low.
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Time between neuromuscular blockade and 20 minutes after completion of endotracheal extubation
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Collaborators and Investigators
Investigators
- Principal Investigator: Ayşın ERSOY, MD, Sultan Abdulhamidhan Training Hospital
- Study Chair: bülent b güven, MD, Sultan Abdulhamidhan Training Hospital
Publications and helpful links
General Publications
- Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
- Kim WS, Byeon GJ, Song BJ, Lee HJ. Availability of preoperative anxiety scale as a predictive factor for hemodynamic changes during induction of anesthesia. Korean J Anesthesiol. 2010 Apr;58(4):328-33. doi: 10.4097/kjae.2010.58.4.328. Epub 2010 Apr 28.
- Ahmetovic-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1423
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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