Clinical trial NCT04690764: Evaluation of the Effects of Preoperative Anxiety in Patients Undergoing Total Intravenous Anesthesia (TIVA)
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption
Keywords: preoperative anxiety, total intravenous anesthesia,
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 Patients undergoing TIVA (Total Intravenous Anesthesia) due to Neuromuscular monitoring during neurosurgery operation.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scores
timeFrame: Pre-surgery baseline to 1 week of postoperation
measure: Total intraoperative opioid consumption
timeFrame: During the neurological surgery
measure: Total intraoperative propofol consumption
timeFrame: During the neurological surgery
Secondary outcomes:
measure: Mean blood pressure change
timeFrame: within 5 minutes after surgical incision
measure: Heart rate change
timeFrame: within 5 minutes after surgical incision
measure: Lowest oxygen saturation
timeFrame: Time between neuromuscular blockade and 20 minutes after completion of endotracheal extubation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bülent Barış güven
Study officials:
affiliation: Sultan Abdulhamidhan Training Hospital
name: Ayşın ERSOY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sultan Abdulhamidhan Training Hospital
name: bülent b güven, MD
role: STUDY_CHAIR
References:
citation: Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
citation: 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.
citation: 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.