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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04690764
Enrollment
80
Registered
2020-12-31
Start date
2019-09-01
Completion date
2021-02-01
Last updated
2020-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption

Keywords

preoperative anxiety, total intravenous anesthesia,

Brief summary

Most patients have varying degrees of anxiety and fear before surgery. We believe that preopertive anxiety levels have an effect on intraoperative hemodynamics and recovery and affect intraoperative drug consumption. Inspired by this idea, we aimed to evaluate the effects of preoperative anxiety on hemodynamics, recovery, and drug consumption in patients undergoing total intravenous anesthesia (TIVA) due to neuromuscular monitoring.

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

Interventions

None listed

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scoresPre-surgery baseline to 1 week of postoperationSTAI 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 consumptionDuring the neurological surgeryThe cumulative remifentanyl (microgram / kilogram) consumption after surgery will be recorded.
Total intraoperative propofol consumptionDuring the neurological surgeryThe cumulative propofol (miligram / kilogram) consumption after surgery will be recorded.

Secondary

MeasureTime frameDescription
Mean blood pressure changewithin 5 minutes after surgical incisionThe 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 changewithin 5 minutes after surgical incisionThe 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 saturationTime between neuromuscular blockade and 20 minutes after completion of endotracheal extubationLowest oxygen saturation will be recorded and values under 95 percent will be considered low.

Countries

Turkey (Türkiye)

Contacts

Primary Contactbülent B güven, MD
barguv@gmail.com05336383445
Backup ContactAyşın ERSOY, MD
drersoy71@hotmail.com0505 7546063

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026