Preoperative Anxiety, Intraoperative Hemodynamics and Drug ConsumptionNCT04690764
Evaluation of the Effects of Preoperative Anxiety in Patients Undergoing Total Intravenous Anesthesia (TIVA)
An observational study of Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 Patients undergoing TIVA (Total Intravenous Anesthesia) due to Neuromuscular monitoring during neurosurgery operation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bülent Barış güven
Istanbul, 34668
Bülent B güven, MD, 05336383445, barguv@gmail.com
Ayşın ERSOY, MD
About this study
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.
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.
Read the 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
- Keywords
- preoperative anxiety, total intravenous anesthesia,
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-surgery baseline to 1 week of postoperation
Total intraoperative opioid consumption
The cumulative remifentanyl (microgram / kilogram) consumption after surgery will be recorded.
Measured: During the neurological surgery
Total intraoperative propofol consumption
The cumulative propofol (miligram / kilogram) consumption after surgery will be recorded.
Measured: During the neurological surgery
Secondary outcomes (3)
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.
Measured: within 5 minutes after surgical incision
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.
Measured: within 5 minutes after surgical incision
Lowest oxygen saturation
Lowest oxygen saturation will be recorded and values under 95 percent will be considered low.
Measured: Time between neuromuscular blockade and 20 minutes after completion of endotracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Sep 2019
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preoperative Anxiety, Intraoperative Hemodynamics and Drug ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bülent Barış Güven, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Ayşın ERSOY, MD, Principal investigator, Sultan Abdulhamidhan Training Hospitalbülent b güven, MD, Study chair, Sultan Abdulhamidhan Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690764
- Sponsor's protocol ID
- 1423
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
PubMed 10589606Kim 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.
PubMed 20508787Ahmetovic-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.
PubMed 29284900
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04690764
- Acronym / sponsor ID
- 1423
- Keywords
- preoperative anxiety, total intravenous anesthesia,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 Patients undergoing TIVA (Total Intravenous Anesthesia) due to Neuromuscular monitoring during neurosurgery operation.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scores
Time frame: 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
Time frame: During the neurological surgery
The cumulative remifentanyl (microgram / kilogram) consumption after surgery will be recorded.
Total intraoperative propofol consumption
Time frame: During the neurological surgery
The cumulative propofol (miligram / kilogram) consumption after surgery will be recorded.
3 secondary outcomes
Mean blood pressure change
Time frame: within 5 minutes after surgical incision
Heart rate change
Time frame: within 5 minutes after surgical incision
Lowest oxygen saturation
Time frame: Time between neuromuscular blockade and 20 minutes after completion of endotracheal extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Results publication: PubMed 10589606Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
- Results publication: PubMed 20508787Kim 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.
- Results publication: PubMed 29284900Ahmetovic-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşın ERSOY, MD principal investigator
Sultan Abdulhamidhan Training Hospital
bülent b güven, MD study chair
Sultan Abdulhamidhan Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anxiety, Intraoperative Hemodynamics and Drug Consumption, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bülent B güven, MD (05336383445, barguv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State-Trait Anxiety Inventory (STAI) questionnaire and anxiety scores (time frame: Pre-surgery baseline to 1 week of postoperation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690764, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.