Do Preoperative Bilirubin Levels Affect Recovery and Hospital Stay After Sedation Anesthesia?

NCT06849661 | Enrolling By Invitation

• 1 other identifier: KAEK/2025.01.4
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

There are still complexities regarding the effects of anesthetic drugs on bilirubin metabolism. The aim of the study was to investigate whether preoperative serum bilirubin levels are associated with the length of hospital stay after ERCP performed under sedation anesthesia in the presence of propofol. Unstable hemodynamics, increased propofol sensitivity, and prolonged recovery time to anesthetics are common features encountered in patients with hyperbilirubinemia. Therefore, close monitoring of cardiovascular functions in these patients and awareness of the possible need for a reduction in the dose of anesthetic used are the expected benefits of the study.

Conditions

Preoperative Biliary Drainage; Recovery Period, Anesthesia; Hospital Length of Stay

Outcome Measures

Primary Outcomes (1)

• Preoperative bilirubin levels and length of hospital stay

  Patients' age, gender, weight in kilograms, height in centimeter, weight and height will be combined to report BMI in kg/m\^2, chronic disease history, medication history, smoking, alcohol, ASA status, being an inpatient or outpatient, Hb (hemoglobin), platelets, Na (sodium), K (potassium), INR (international normalized ratio), total bilirubin, direct bilirubin, indirect bilirubin, ALP (Alkaline phosphatase), ALT (Alanine aminotransferase), AST (aspartate aminotransferase), and hospital stay will be recorded by reviewing the case follow-up forms.

  from the beginning of the enrollment until 1 month after sedation anesthesia recovery

Study Arms (2)

Arm Low Bilirubine Levels

Arm High Bilirubine Levels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on patients who applied to the anesthesia polyclinic of SBU University Kanuni Sultan Süleyman E.A.H. and were scheduled to undergo ERCP under sedation. A total of 360 patients over the age of 18, ASA I-IV status, of both genders, who will undergo an ERCP procedure under sedation anesthesia will be included in the study.

You may qualify if:

• years of age and older
• ASA I-IV status
• Both genders
• To be operated under sedation anesthesia for ERCP procedure

You may not qualify if:

• age \<18
• pregnancy
• lack of informed consent (such as patients with mental retardation or
• language problems)
• history of allergy to any agent used during sedation
• baseline O2 saturation \<90%
• baseline systolic blood pressure \<90 mmHg
• procedure performed under general anesthesia

Sponsors & Collaborators

• Naime Yalçın: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bilirubines (Total,direct,indirect), Amylase, AST, ALT, ALP

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Anesthesiology and Reanimation, Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 27, 2025
• Study Start: January 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

TU (1)