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Completed

NCT Number: NCT06093789

The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ondokuz Mayis University

Samsun, Atakum, 55000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBQ-S1

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

    The amount of iv propofol administered until the Ramsey Sedation Score of 4 is obtained

  3. 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.

  4. Heart rate (beats/min)

    Time frame: every 5 minutes during the procedure.

    It will be monitored and documented every 5 minutes during the procedure.

  5. Peripheral oxygen saturation (%)

    Time frame: every 5 minutes during the procedure

    (%): It will be monitored and documented every 5 minutes during the procedure.

  6. Number of Involuntary movement during the procedure

    Time frame: during the procedure.

    The presence of involuntary movement will be documented during the procedure.

  7. 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)

  8. Analgesic consumption

    Time frame: postoperatively up to 2 hours

    The analgesic agents administered to the patients throughout the postoperative period will be documented.

  9. Postoperative recovery time

    Time frame: postoperatively up to 2 hours

    The time until the Modified Aldrete Score reaches 9 points will be determined.

  10. The incidences of post-operative nausea and vomiting (PONV)

    Time frame: the time from the end of the procedure until discharge

    the presence of nausea and vomiting will be recorded for 24 hours after procedure

  11. Undesirable events and interventions

    Time frame: time between start of procedure and discharge

    Bradycardia, hypotension, airway obstruction, hypoxia will be documented throughout the perioperative phase with the intervention.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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