The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption

Completed

• Conditions: Infertility; Anesthesia
• Interventions: Other: PBQ-S1

• Registration Number: NCT06093789
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Study Start: 2023-11-01
• Primary Completion: 2024-03-30
• Study Completion: 2024-07-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group PT-PADC	PBQ-S1	patients who will receive sedoanalgesia for the oocyte retrieval procedure.

Primary Outcome Measures

Name	Time	Method
Propofol consumption	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

Secondary Outcome Measures

Name	Time	Method
Amount of propofol (mg) used until the required sedation depth is reached	The period of time starting with the propofol injection until the Ramsey Sedation Score of 4	The amount of iv propofol administered until the Ramsey Sedation Score of 4 is obtained
Peripheral oxygen saturation (%)	every 5 minutes during the procedure	(%): It will be monitored and documented every 5 minutes during the procedure.
Number of Involuntary movement during the procedure	during the procedure.	The presence of involuntary movement will be documented during the procedure.
Postoperative pain (visual analog scale)	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)
Heart rate (beats/min)	every 5 minutes during the procedure.	It will be monitored and documented every 5 minutes during the procedure.
Time until the Ramsey Sedation Score of 4 is reached	-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.
Systolic, diastolic and, mean Blood pressure (mm/Hg)	every 5 minutes during the procedure	It will be monitored and documented every 5 minutes during the procedure.
Analgesic consumption	postoperatively up to 2 hours	The analgesic agents administered to the patients throughout the postoperative period will be documented.
Postoperative recovery time	postoperatively up to 2 hours	The time until the Modified Aldrete Score reaches 9 points will be determined.
The incidences of post-operative nausea and vomiting (PONV)	the time from the end of the procedure until discharge	the presence of nausea and vomiting will be recorded for 24 hours after procedure
Undesirable events and interventions	time between start of procedure and discharge	Bradycardia, hypotension, airway obstruction, hypoxia will be documented throughout the perioperative phase with the intervention.

Trial Locations

Locations (1)

Ondokuz Mayis University; 🇹🇷 Samsun, Atakum, Turkey