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Evaluation of the Effects of Preoperative Anxiety in Patients Undergoing Total Intravenous Anesthesia (TIVA)

NCT ID: NCT04690764

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-02-01

Brief Summary

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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

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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

Conditions

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Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption

Keywords

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preoperative anxiety, total intravenous anesthesia,

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Bülent Barış Güven

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşın ERSOY, MD

Role: PRINCIPAL_INVESTIGATOR

Sultan Abdulhamidhan Training Hospital

bülent b güven, MD

Role: STUDY_CHAIR

Sultan Abdulhamidhan Training Hospital

Locations

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Bülent Barış güven

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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bülent B güven, MD

Role: CONTACT

Phone: 05336383445

Email: [email protected]

Ayşın ERSOY, MD

Role: CONTACT

Phone: 0505 7546063

Email: [email protected]

Facility Contacts

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Bülent B güven, MD

Role: primary

References

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Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.

Reference Type RESULT
PMID: 10589606 (View on PubMed)

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.

Reference Type RESULT
PMID: 20508787 (View on PubMed)

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.

Reference Type RESULT
PMID: 29284900 (View on PubMed)

Other Identifiers

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1423

Identifier Type: -

Identifier Source: org_study_id