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

Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690764
• Other study ID #: 1423
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: December 2020
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: bülent B güven, MD
• Phone: 05336383445
• Email: barguv[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption

Locations

Country	Name	City	State
Turkey	Bülent Baris güven	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View Citation

Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scores	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.	Pre-surgery baseline to 1 week of postoperation
Primary	Total intraoperative opioid consumption	The cumulative remifentanyl (microgram / kilogram) consumption after surgery will be recorded.	During the neurological surgery
Primary	Total intraoperative propofol consumption	The cumulative propofol (miligram / kilogram) consumption after surgery will be recorded.	During the neurological surgery
Secondary	Mean blood pressure change	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.	within 5 minutes after surgical incision
Secondary	Heart rate change	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.	within 5 minutes after surgical incision
Secondary	Lowest oxygen saturation	Lowest oxygen saturation will be recorded and values under 95 percent will be considered low.	Time between neuromuscular blockade and 20 minutes after completion of endotracheal extubation