The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption

Infertility Clinical Trial

Official title:

The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06093789
• Other study ID #: PT-PADC
• Status: Active, not recruiting
• Start date: November 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: April 2024
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Infertility

Intervention

Other:
• PBQ-S1
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.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propofol consumption	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	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.	-The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
Secondary	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	The period of time starting with the propofol injection until the Ramsey Sedation Score of 4
Secondary	Systolic, diastolic and, mean Blood pressure (mm/Hg)	It will be monitored and documented every 5 minutes during the procedure.	every 5 minutes during the procedure
Secondary	Heart rate (beats/min)	It will be monitored and documented every 5 minutes during the procedure.	every 5 minutes during the procedure.
Secondary	Peripheral oxygen saturation (%)	(%): It will be monitored and documented every 5 minutes during the procedure.	every 5 minutes during the procedure
Secondary	Number of Involuntary movement during the procedure	The presence of involuntary movement will be documented during the procedure.	during the procedure.
Secondary	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)	After the procedure,every 30 minutes up to 1 hour
Secondary	Analgesic consumption	The analgesic agents administered to the patients throughout the postoperative period will be documented.	postoperatively up to 2 hours
Secondary	Postoperative recovery time	The time until the Modified Aldrete Score reaches 9 points will be determined.	postoperatively up to 2 hours
Secondary	The incidences of post-operative nausea and vomiting (PONV)	the presence of nausea and vomiting will be recorded for 24 hours after procedure	the time from the end of the procedure until discharge
Secondary	Undesirable events and interventions	Bradycardia, hypotension, airway obstruction, hypoxia will be documented throughout the perioperative phase with the intervention.	time between start of procedure and discharge