Evaluation of the Effects of Preoperative Anxiety in Patients Undergoing Total Intravenous Anesthesia (TIVA)
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| ClinicalTrials.gov Identifier: NCT04690764 |
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Recruitment Status :
Recruiting
First Posted : December 31, 2020
Last Update Posted : December 31, 2020
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| Condition or disease |
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| Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption |
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 : | Observational |
| Estimated Enrollment : | 80 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of the Effects of Preoperative Anxiety on Hemodynamics, Recovery and Drug Consumption in Patients Undergoing Total Intravenous Anesthesia (TIVA) for Neuromuscular Monitoring. |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | February 1, 2021 |
| Estimated Study Completion Date : | February 1, 2021 |
- 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.
- Total intraoperative opioid consumption [ Time Frame: During the neurological surgery ]The cumulative remifentanyl (microgram / kilogram) consumption after surgery will be recorded.
- Total intraoperative propofol consumption [ Time Frame: During the neurological surgery ]The cumulative propofol (miligram / kilogram) consumption after surgery will be recorded.
- 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.
- 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.
- Lowest oxygen saturation [ Time Frame: Time between neuromuscular blockade and 20 minutes after completion of endotracheal extubation ]Lowest oxygen saturation will be recorded and values under 95 percent will be considered low.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690764
| Contact: bülent B güven, MD | 05336383445 | barguv@gmail.com | |
| Contact: Ayşın ERSOY, MD | 0505 7546063 | drersoy71@hotmail.com |
| Turkey | |
| Bülent Barış güven | Recruiting |
| Istanbul, Turkey, 34668 | |
| Contact: Bülent B güven, MD 05336383445 barguv@gmail.com | |
| Principal Investigator: Ayşın ERSOY, MD | |
| Principal Investigator: | Ayşın ERSOY, MD | Sultan Abdulhamidhan Training Hospital | |
| Study Chair: | bülent b güven, MD | Sultan Abdulhamidhan Training Hospital |
| Responsible Party: | Bülent Barış Güven, Anesthesiologist, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
| ClinicalTrials.gov Identifier: | NCT04690764 |
| Other Study ID Numbers: |
1423 |
| First Posted: | December 31, 2020 Key Record Dates |
| Last Update Posted: | December 31, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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preoperative anxiety, total intravenous anesthesia, |
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Anxiety Disorders Mental Disorders |