The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06093789
Collaborator
(none)
90
1
8.9
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PBQ-S1

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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Relationship Between Personality Traits and Perioperative Anesthetic Drug Consumption
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Group PT-PADC

patients who will receive sedoanalgesia for the oocyte retrieval procedure.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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.

  4. Heart rate (beats/min) [every 5 minutes during the procedure.]

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

  5. Peripheral oxygen saturation (%) [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 [during the procedure.]

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

  7. 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)

  8. Analgesic consumption [postoperatively up to 2 hours]

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

  9. Postoperative recovery time [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) [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 between start of procedure and discharge]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ondokuz Mayis University Samsun Atakum Turkey 55000

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
SEZGİN BİLGİN, MD, Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT06093789
Other Study ID Numbers:
  • PT-PADC
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SEZGİN BİLGİN, MD, Ondokuz Mayıs University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023