Estrogen and Propofol Injection Pain

NCT ID: NCT06929416

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2025-09-10

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.

Detailed Description

This prospective observational study aims to evaluate the association between serum estrogen levels and the incidence and severity of propofol injection pain (PIP) in adult female patients undergoing general anesthesia. Although propofol is a widely used intravenous anesthetic, it frequently causes pain upon injection. Estrogen is believed to play a role in modulating pain perception and inflammatory responses, yet the effects of elevated estrogen levels on PIP are not well understood.

The study will be conducted at a single tertiary hospital and will include 90 ASA I-II female patients aged 18-45 years. One group will consist of IVF patients with elevated serum estradiol levels due to controlled ovarian stimulation. The control group will include patients with normal estradiol levels scheduled for elective procedures under general anesthesia. Preoperative serum estradiol levels will be recorded, and injection pain will be evaluated using a validated four-point behavioral pain scale based on vocal response, facial expression, limb movement, and tearfulness.

Anesthesia induction will follow standard clinical practice without additional interventions. Pain data will be collected through routine clinical observation. The results may offer new insights into hormonal modulation of acute nociceptive responses and help improve patient experiences during anesthesia.

Conditions

Pain; Estradiol; Assisted Reproductive Techniques

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Women Undergoing IVF With Supraphysiological Estrogen Levels

No interventions assigned to this group

2

Women Undergoing Elective Surgery With Normal Estrogen Levels

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmut Tutar, MD

Role: STUDY_CHAIR

KONYA CITY HOSPİTAL

Locations

Konya City Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2.02.2025-35906

Identifier Type: -

Identifier Source: org_study_id