Clinical trial NCT06093789: The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption
Official title: The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Infertility
Keywords: Personality traits
Anesthetic Drug Consumption
Anxiety
Acute pain
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients between 18-50 ages who will undergo oocyte pick up procedure with sedation

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Propofol consumption
timeFrame: from the beginning to the end of the transvaginal oocyte retrieval procedure)
Secondary outcomes:
measure: Time until the Ramsey Sedation Score of 4 is reached
timeFrame: -The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
measure: Amount of propofol (mg) used until the required sedation depth is reached
timeFrame: The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
measure: Systolic, diastolic and, mean Blood pressure (mm/Hg)
timeFrame: every 5 minutes during the procedure
measure: Heart rate (beats/min)
timeFrame: every 5 minutes during the procedure.
measure: Peripheral oxygen saturation (%)
timeFrame: every 5 minutes during the procedure
measure: Number of Involuntary movement during the procedure
timeFrame: during the procedure.
measure: Postoperative pain (visual analog scale)
timeFrame: After the procedure,every 30 minutes up to 1 hour
measure: Analgesic consumption
timeFrame: postoperatively up to 2 hours
measure: Postoperative recovery time
timeFrame: postoperatively up to 2 hours
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: the time from the end of the procedure until discharge
measure: Undesirable events and interventions
timeFrame: time between start of procedure and discharge
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
References:
citation: 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.
citation: Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
citation: 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.