Estrogen and Propofol Injection Pain

NCT06929416 | Completed

• 1 other identifier: 2.02.2025-35906
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study investigates the relationship between serum estrogen concentration and the incidence and severity of propofol injection pain (PIP) in female patients undergoing general anesthesia. The study will include 90 ASA I-II female patients aged 18-45. One group will consist of IVF patients with elevated estrogen levels, while the control group will include patients with normal estrogen levels undergoing other elective procedures. Pain will be assessed using a standardized four-point behavioral pain scale. The findings may enhance understanding of hormonal influences on pain and contribute to improving patient comfort during anesthesia induction.

Conditions

Pain; Estradiol; Assisted Reproductive Techniques

Outcome Measures

Primary Outcomes (1)

• Incidence of Propofol Injection Pain

  Presence or absence of pain during propofol injection, assessed through patient response (verbal reaction, facial grimacing, arm withdrawal, or tearing) and/or verbal confirmation during anesthesia induction. Comparison between patients with normal and supraphysiological estradiol levels.

  Immediately during induction of anesthesia

Secondary Outcomes (2)

• Severity of Propofol Injection Pain

  Immediately during induction of anesthesia

• Postoperative Injection Site Reactions

  Within 24 hours after surgery

Study Arms (2)

1

Women Undergoing IVF With Supraphysiological Estrogen Levels

2

Women Undergoing Elective Surgery With Normal Estrogen Levels

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult female patients aged 18 to 45 years, with ASA physical status I or II, who are scheduled for elective surgical procedures under general anesthesia. Participants will be divided into two groups based on their preoperative serum estradiol levels: one group will include women undergoing IVF procedures with supraphysiological estrogen levels, and the other will consist of patients with normal estrogen levels undergoing unrelated elective surgeries.

You may qualify if:

• Female patients aged between 18 and 45 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Scheduled for surgery under general anesthesia
• Availability of a preoperative serum estradiol (E2) level
• For Group 1: Undergoing IVF procedure with supraphysiological E2 levels (\>350 pg/mL)
• For Group 2: Undergoing elective surgery with normal E2 levels (15-350 pg/mL)

You may not qualify if:

• ASA physical status III or IV
• Pregnant patients
• Perimenopausal women
• Male patients
• Patients younger than 18 or older than 45 years
• History of psychiatric disorders
• Patients undergoing emergency surgery

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmut Tutar, MD

  KONYA CITY HOSPİTAL

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: May 2, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)