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

• Conditions: Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption

• Registration Number: NCT04690764
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-29
• Last Update Submitted: 2020-12-29
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total intraoperative propofol consumption	During the neurological surgery	The cumulative propofol (miligram / kilogram) consumption after surgery will be recorded.
Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scores	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	During the neurological surgery	The cumulative remifentanyl (microgram / kilogram) consumption after surgery will be recorded.

Secondary Outcome Measures

Name	Time	Method
Mean blood pressure change	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	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 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.

Trial Locations

Locations (1)

Bülent Barış güven; 🇹🇷 Istanbul, Turkey