AnesthesiaNCT06093789
The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption
An observational study of Anesthesia and Infertility, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to examine the association between personality traits and amount of anesthetic drug consumption,of the patients who will receive sedoanalgesia for the oocyte retrieval procedure. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Anesthesia, Infertility
- What is being tested?
- PBQ-S1
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Jul 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients between 18-50 ages who will undergo oocyte pick up procedure with sedation
Who may be able to join
- 18- 50 year-old elective patients who signed the informed consent form from ASA I-II patients scheduled for oocyte retrieval.
- Patients with sufficient education and mental capacity to complete in assessment scales and questionnaires.
- Patients without neurological disorders, psychological illnesses, or drug or alcohol abuse
- Patients without stimulant drug and alcohol consumption
- Absence of significant cardiovascular, respiratory, kidney or liver disease.
Who cannot join
- Psychiatric or neurological disorder
- Psychiatric drug use or alcohol consumption
- Pregnancy
- Presence of severe cardiac, hepatic or cerebrovascular disease
- History of allergy to local anesthetics or systemic opioids
- History of chronic pain
- Patients who are unable to evaluate scales and questionnaires
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55000
About this study
In this study, we aimed to examine the association between personality traits and amount of anesthetic drug consumption,of the patients who will receive sedoanalgesia for the oocyte retrieval procedure. As well as determining the anxiety scores in the preoperative period, the time to reach the desired sedation level, hemodynamic parameters in the perioperative period, peripheral oxygen saturation, EtCO2 value, postoperative pain, postanesthetic recovery, analgesic drug need, unconscious movement, and patient satisfaction.
Read the detailed description
Different personality traits, anxiety disorders, depression, and somatoform disorders are frequently encountered in women with infertility problems. Although there are many studies evaluating the relationship of anxiety with variables such as hemodynamic parameters, need for anesthetic medication, recovery times, postoperative pain and analgesic requirements, the relationship between personality traits and these variables has not been investigated.
In our study, considering that the anesthesia needs of these patients with a stressful negative factor such as infertility may be at different levels, preoperative evaluation of the patients with a personality questionnaire will provide better perioperative management, a better quality recovery and possibly a higher quality oocyte aspiration. In this study, it was aimed to investigate the amount of anesthetic agent consumption, recovery times, postoperative pain scores, analgesic requirements, involuntary movement, time to reach sufficient sedation depth, and patient satisfaction of patients thought to have sedation.
All patients will fill out Personality Belief Scale-Short Form (PBQ-S1) and Beck Anxiety Scale one day before the procedure and they will be registered.
- Conditions
- Anesthesia, Infertility
- Being tested
- PBQ-S1
- Keywords
- Personality traits, Anesthetic Drug Consumption, Anxiety, Acute pain
- Medical subject headings
- Infertility, Anxiety Disorders, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBQ-S1Other
All patients will fill out Personality Belief Scale-Short Form (PBQ-S1) and Beck Anxiety Scale one day before the procedure and they will be registered.
| Study group | Role | What they receive |
|---|---|---|
| Group PT-PADC | patients who will receive sedoanalgesia for the oocyte retrieval procedure. Receives: Other: PBQ-S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol consumption
mg, from the beginning to the end of the transvaginal oocyte retrieval procedure
Measured: from the beginning to the end of the transvaginal oocyte retrieval procedure)
Secondary outcomes (11)
Time until the Ramsey Sedation Score of 4 is reached
The period elapsed after the patient is transported to the operating table and the sedation protocol begins.
Measured: -The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
Amount of propofol (mg) used until the required sedation depth is reached
The amount of iv propofol administered until the Ramsey Sedation Score of 4 is obtained
Measured: The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
Systolic, diastolic and, mean Blood pressure (mm/Hg)
It will be monitored and documented every 5 minutes during the procedure.
Measured: every 5 minutes during the procedure
Heart rate (beats/min)
It will be monitored and documented every 5 minutes during the procedure.
Measured: every 5 minutes during the procedure.
Peripheral oxygen saturation (%)
(%): It will be monitored and documented every 5 minutes during the procedure.
Measured: every 5 minutes during the procedure
Number of Involuntary movement during the procedure
The presence of involuntary movement will be documented during the procedure.
Measured: during the procedure.
Postoperative pain (visual analog scale)
Pain status will be evaluated based on visual analog scale (VAS) at rest and after movement.every 30-minute intervals for one hour in the recovery room. Each VAS is scores 0-10 (0=no pain, 10=unbearable pain)
Measured: After the procedure,every 30 minutes up to 1 hour
Analgesic consumption
The analgesic agents administered to the patients throughout the postoperative period will be documented.
Measured: postoperatively up to 2 hours
Postoperative recovery time
The time until the Modified Aldrete Score reaches 9 points will be determined.
Measured: postoperatively up to 2 hours
The incidences of post-operative nausea and vomiting (PONV)
the presence of nausea and vomiting will be recorded for 24 hours after procedure
Measured: the time from the end of the procedure until discharge
Undesirable events and interventions
Bradycardia, hypotension, airway obstruction, hypoxia will be documented throughout the perioperative phase with the intervention.
Measured: time between start of procedure and discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Mar 2024
- Study completion30 Jul 2024
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEZGİN BİLGİN, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093789
- Sponsor's protocol ID
- PT-PADC
- Status last verified
- Mar 2025
- First submitted
- 10 Jul 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SS, Kim HH, Park HJ. Are Histrionic Personality Traits Associated with Irritability during Conscious Sedation Endoscopy? Gastroenterol Res Pract. 2015;2015:702492. doi: 10.1155/2015/702492. Epub 2015 Apr 12.
PubMed 25954307Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
PubMed 10589606CLARIDGE GS, HERRINGTON RN. Sedation threshold, personality, and the theory of neurosis. J Ment Sci. 1960 Oct;106:1568-83. doi: 10.1192/bjp.106.445.1568. No abstract available.
PubMed 13693809
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption
- ClinicalTrials.gov ID
- NCT06093789
- Acronym / sponsor ID
- PT-PADC
- Conditions
- Anesthesia, Infertility
- Keywords
- Personality traits, Anesthetic Drug Consumption, Anxiety, Acute pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 23 Oct 2023 (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.
In this study, we aimed to examine the association between personality traits and amount of anesthetic drug consumption,of the patients who will receive sedoanalgesia for the oocyte retrieval procedure. As well as determining the anxiety scores in the preoperative period, the time to reach the desired sedation level, hemodynamic parameters in the perioperative period, peripheral oxygen saturation, EtCO2 value, postoperative pain, postanesthetic recovery, analgesic drug need, unconscious movement, and patient satisfaction.
Detailed description
Different personality traits, anxiety disorders, depression, and somatoform disorders are frequently encountered in women with infertility problems. Although there are many studies evaluating the relationship of anxiety with variables such as hemodynamic parameters, need for anesthetic medication, recovery times, postoperative pain and analgesic requirements, the relationship between personality traits and these variables has not been investigated.
In our study, considering that the anesthesia needs of these patients with a stressful negative factor such as infertility may be at different levels, preoperative evaluation of the patients with a personality questionnaire will provide better perioperative management, a better quality recovery and possibly a higher quality oocyte aspiration. In this study, it was aimed to investigate the amount of anesthetic agent consumption, recovery times, postoperative pain scores, analgesic requirements, involuntary movement, time to reach sufficient sedation depth, and patient satisfaction of patients thought to have sedation.
All patients will fill out Personality Belief Scale-Short Form (PBQ-S1) and Beck Anxiety Scale one day before the procedure and they will be registered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group PT-PADC | – | Other: PBQ-S1patients who will receive sedoanalgesia for the oocyte retrieval procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients between 18-50 ages who will undergo oocyte pick up procedure with sedation
Key inclusion criteria (5 listed)
- 18- 50 year-old elective patients who signed the informed consent form from ASA I-II patients scheduled for oocyte retrieval.
- Patients with sufficient education and mental capacity to complete in assessment scales and questionnaires.
- Patients without neurological disorders, psychological illnesses, or drug or alcohol abuse
- Patients without stimulant drug and alcohol consumption
- Absence of significant cardiovascular, respiratory, kidney or liver disease.
Key exclusion criteria (7 listed)
- Psychiatric or neurological disorder
- Psychiatric drug use or alcohol consumption
- Pregnancy
- Presence of severe cardiac, hepatic or cerebrovascular disease
- History of allergy to local anesthetics or systemic opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBQ-S1All patients will fill out Personality Belief Scale-Short Form (PBQ-S1) and Beck Anxiety Scale one day before the procedure and they will be registered. | Other | Group PT-PADC |
Primary outcome
Propofol consumption
Time frame: from the beginning to the end of the transvaginal oocyte retrieval procedure)
mg, from the beginning to the end of the transvaginal oocyte retrieval procedure
11 secondary outcomes
Time until the Ramsey Sedation Score of 4 is reached
Time frame: -The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
Amount of propofol (mg) used until the required sedation depth is reached
Time frame: The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
Systolic, diastolic and, mean Blood pressure (mm/Hg)
Time frame: every 5 minutes during the procedure
Heart rate (beats/min)
Time frame: every 5 minutes during the procedure.
Peripheral oxygen saturation (%)
Time frame: every 5 minutes during the procedure
Number of Involuntary movement during the procedure
Time frame: during the procedure.
Postoperative pain (visual analog scale)
Time frame: After the procedure,every 30 minutes up to 1 hour
Analgesic consumption
Time frame: postoperatively up to 2 hours
Postoperative recovery time
Time frame: postoperatively up to 2 hours
The incidences of post-operative nausea and vomiting (PONV)
Time frame: the time from the end of the procedure until discharge
Undesirable events and interventions
Time frame: time between start of procedure and discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 25954307Lee SS, Kim HH, Park HJ. Are Histrionic Personality Traits Associated with Irritability during Conscious Sedation Endoscopy? Gastroenterol Res Pract. 2015;2015:702492. doi: 10.1155/2015/702492. Epub 2015 Apr 12.
- Background: 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.
- Background: PubMed 13693809CLARIDGE GS, HERRINGTON RN. Sedation threshold, personality, and the theory of neurosis. J Ment Sci. 1960 Oct;106:1568-83. doi: 10.1192/bjp.106.445.1568. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia and Infertility, run by Ondokuz Mayıs University 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol consumption (time frame: from the beginning to the end of the transvaginal oocyte retrieval procedure)). 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 NCT06093789, 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 1 Apr 2025.