- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06093789
The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Atakum
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Samsun, Atakum, Turkey, 55000
- Ondokuz Mayis University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group PT-PADC
patients who will receive sedoanalgesia for the oocyte retrieval procedure.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
from the beginning to the end of the transvaginal oocyte retrieval procedure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The period elapsed after the patient is transported to the operating table and the sedation protocol begins.
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-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
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The amount of iv propofol administered until the Ramsey Sedation Score of 4 is obtained
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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
|
It will be monitored and documented every 5 minutes during the procedure.
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every 5 minutes during the procedure
|
|
Heart rate (beats/min)
Time Frame: every 5 minutes during the procedure.
|
It will be monitored and documented every 5 minutes during the procedure.
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every 5 minutes during the procedure.
|
|
Peripheral oxygen saturation (%)
Time Frame: every 5 minutes during the procedure
|
(%): It will be monitored and documented every 5 minutes during the procedure.
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every 5 minutes during the procedure
|
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Number of Involuntary movement during the procedure
Time Frame: during the procedure.
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The presence of involuntary movement will be documented during the procedure.
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during the procedure.
|
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Postoperative pain (visual analog scale)
Time Frame: After the procedure,every 30 minutes up to 1 hour
|
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)
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After the procedure,every 30 minutes up to 1 hour
|
|
Analgesic consumption
Time Frame: postoperatively up to 2 hours
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The analgesic agents administered to the patients throughout the postoperative period will be documented.
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postoperatively up to 2 hours
|
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Postoperative recovery time
Time Frame: postoperatively up to 2 hours
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The time until the Modified Aldrete Score reaches 9 points will be determined.
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postoperatively up to 2 hours
|
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The incidences of post-operative nausea and vomiting (PONV)
Time Frame: the time from the end of the procedure until discharge
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the presence of nausea and vomiting will be recorded for 24 hours after procedure
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the time from the end of the procedure until discharge
|
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Undesirable events and interventions
Time Frame: time between start of procedure and discharge
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Bradycardia, hypotension, airway obstruction, hypoxia will be documented throughout the perioperative phase with the intervention.
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time between start of procedure and discharge
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- CLARIDGE 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT-PADC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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