Preoperative Biliary DrainageNCT06849661
Do Preoperative Bilirubin Levels Affect Recovery and Hospital Stay After Sedation Anesthesia?
An observational study of Preoperative Biliary Drainage and Recovery Period, Anesthesia, run by Naime Yalçın at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Biliary Drainage, Recovery Period, Anesthesia, Hospital Length of Stay
- How many people
- 360 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 1 Oct 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years of age and older
- ASA I-IV status
- Both genders
- To be operated under sedation anesthesia for ERCP procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34000
About this study
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.
Read the detailed description
Bilirubin is a lipid-soluble substance produced as the end product of heme metabolism in mammals. It easily crosses cell membranes, including the blood-brain barrier (BBB), and has been reported to have both neuroprotective and neurotoxic effects. Most bilirubin binds to albumin, but unbound bilirubin crosses the BBB, binds to nerve cells, and exhibits cytotoxic effects. Neurological symptoms resulting from hyperbilirubinemia are common in neonates, but decrease after BBB maturation. However, patients may be susceptible/vulnerable to neurological complications as a result of liver cirrhosis, decreased albumin production, or drug-induced displacement of bilirubin from albumin binding sites. It can also cause a blood-brain barrier dysfunction in situations such as anesthesia/surgery. In addition to playing a protective role, bilirubin also plays a role in the progression of neurological dysfunction in many pathological conditions. Many of these conditions elevate bilirubin concentrations above physiological levels, where the toxic effects of bilirubin begin to outweigh its protective antioxidant benefits and damage the nervous system. Bilirubin becomes neurotoxic when it reaches micromolar concentrations, the same level at which it aggregates and adheres to cell membranes, disrupting normal cell function. High bilirubin levels, or hyperbilirubinemia, are classically defined as bilirubin levels greater than 3 mg/dL and should typically be considered a sign of an underlying disease state. Jaundice is often a symptom of underlying liver and biliary tract disease. Hyperbilirubinemia most often refers to liver/biliary tract disease, but it can be the result of a variety of hereditary causes or can also be caused by hematologic disorders. Endoscopic retrograde cholangiopancreatography (ERCP) was initially developed in 1968 as an important diagnostic tool for biliary and pancreatic diseases. Patients were injected with a dye and referred to an interventional radiologist or a surgeon for further treatment if necessary. Dr. William S. McCune performed the first successful ERCP using a fiber duodenoscope. In 1972, Dr. Peter Cotton described cannulation in 60 patients. The following year, Dr. Meinhard Classen in Germany and Dr. Keiichi Kawai in Japan simultaneously performed the first biliary sphincterotomy. ERCP has moved from being a diagnostic tool to a therapeutic tool. The complication and mortality rates associated with ERCP have been reported as 5% to 10% and 0.1% to 1%, respectively. It is a complex and time-consuming procedure that can be performed with deep sedation or general anesthesia. There is no consensus on the best anesthetic application between deep sedation and general anesthesia. While benzodiazepines and opioids have traditionally been used for sedation, propofol has recently become popular worldwide. Propofol has a rapid onset and end of action, and its hypnotic properties provide patient comfort and amnesia. This ultimately leads to faster recovery and increased ERCP success and satisfaction. Complications such as respiratory depression and hypoxemia are observed in association with sedation, with a frequency ranging from 2% to 26%. The incidence is directly proportional to the duration of the procedure, and the odds ratio increases from 1.8 in procedures lasting less than 10 minutes to 7.9 in procedures lasting more than 1 hour. The ability of drugs used in anesthesia to remove bilirubin from albumin has not been studied adequately. There is no specific data on the protein binding of propofol, but it is known that propofol removes bilirubin induced by fatty acid components from albumin, causing an increase in free bilirubin. However, one study indicated that the concentration of unconjugated bilirubin is generally relatively small and that the effect of propofol on albumin binding is insignificant. It was stated that the main issue to be considered is the possible effects of this large number of conjugated bilirubins on propofol binding. It was stated that conjugated bilirubin is water soluble and the two propofol regions in human serum albumin are hydrophobic; therefore, it is unlikely that conjugated bilirubin will compete with propofol at these sites. Another study has suggested that although bilirubin levels do not change the free concentration of propofol, the free concentration of propofol may increase significantly if the human serum albumin concentration in these patients with impaired liver function falls significantly.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm Low Bilirubine Levels | Not described | |
| Arm High Bilirubine Levels | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the beginning of the enrollment until 1 month after sedation anesthesia recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Jan 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Biliary DrainageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Naime Yalçın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849661
- Sponsor's protocol ID
- KAEK/2025.01.4
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Preoperative Bilirubin Levels Affect Recovery and Hospital Stay After Sedation Anesthesia?
- ClinicalTrials.gov ID
- NCT06849661
- Acronym / sponsor ID
- KAEK/2025.01.4
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Naime YalçınUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bilirubin is a lipid-soluble substance produced as the end product of heme metabolism in mammals. It easily crosses cell membranes, including the blood-brain barrier (BBB), and has been reported to have both neuroprotective and neurotoxic effects. Most bilirubin binds to albumin, but unbound bilirubin crosses the BBB, binds to nerve cells, and exhibits cytotoxic effects. Neurological symptoms resulting from hyperbilirubinemia are common in neonates, but decrease after BBB maturation. However, patients may be susceptible/vulnerable to neurological complications as a result of liver cirrhosis, decreased albumin production, or drug-induced displacement of bilirubin from albumin binding sites. It can also cause a blood-brain barrier dysfunction in situations such as anesthesia/surgery. In addition to playing a protective role, bilirubin also plays a role in the progression of neurological dysfunction in many pathological conditions. Many of these conditions elevate bilirubin concentrations above physiological levels, where the toxic effects of bilirubin begin to outweigh its protective antioxidant benefits and damage the nervous system. Bilirubin becomes neurotoxic when it reaches micromolar concentrations, the same level at which it aggregates and adheres to cell membranes, disrupting normal cell function. High bilirubin levels, or hyperbilirubinemia, are classically defined as bilirubin levels greater than 3 mg/dL and should typically be considered a sign of an underlying disease state. Jaundice is often a symptom of underlying liver and biliary tract disease. Hyperbilirubinemia most often refers to liver/biliary tract disease, but it can be the result of a variety of hereditary causes or can also be caused by hematologic disorders. Endoscopic retrograde cholangiopancreatography (ERCP) was initially developed in 1968 as an important diagnostic tool for biliary and pancreatic diseases. Patients were injected with a dye and referred to an interventional radiologist or a surgeon for further treatment if necessary. Dr. William S. McCune performed the first successful ERCP using a fiber duodenoscope. In 1972, Dr. Peter Cotton described cannulation in 60 patients. The following year, Dr. Meinhard Classen in Germany and Dr. Keiichi Kawai in Japan simultaneously performed the first biliary sphincterotomy. ERCP has moved from being a diagnostic tool to a therapeutic tool. The complication and mortality rates associated with ERCP have been reported as 5% to 10% and 0.1% to 1%, respectively. It is a complex and time-consuming procedure that can be performed with deep sedation or general anesthesia. There is no consensus on the best anesthetic application between deep sedation and general anesthesia. While benzodiazepines and opioids have traditionally been used for sedation, propofol has recently become popular worldwide. Propofol has a rapid onset and end of action, and its hypnotic properties provide patient comfort and amnesia. This ultimately leads to faster recovery and increased ERCP success and satisfaction. Complications such as respiratory depression and hypoxemia are observed in association with sedation, with a frequency ranging from 2% to 26%. The incidence is directly proportional to the duration of the procedure, and the odds ratio increases from 1.8 in procedures lasting less than 10 minutes to 7.9 in procedures lasting more than 1 hour. The ability of drugs used in anesthesia to remove bilirubin from albumin has not been studied adequately. There is no specific data on the protein binding of propofol, but it is known that propofol removes bilirubin induced by fatty acid components from albumin, causing an increase in free bilirubin. However, one study indicated that the concentration of unconjugated bilirubin is generally relatively small and that the effect of propofol on albumin binding is insignificant. It was stated that the main issue to be considered is the possible effects of this large number of conjugated bilirubins on propofol binding. It was stated that conjugated bilirubin is water soluble and the two propofol regions in human serum albumin are hydrophobic; therefore, it is unlikely that conjugated bilirubin will compete with propofol at these sites. Another study has suggested that although bilirubin levels do not change the free concentration of propofol, the free concentration of propofol may increase significantly if the human serum albumin concentration in these patients with impaired liver function falls significantly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Low Bilirubine Levels | – | – |
| Arm High Bilirubine Levels | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 18 years of age and older
- ASA I-IV status
- Both genders
- To be operated under sedation anesthesia for ERCP procedure
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative bilirubin levels and length of hospital stay
Time frame: from the beginning of the enrollment until 1 month after sedation anesthesia recovery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Biliary Drainage and Recovery Period, Anesthesia, run by Naime Yalçın at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative bilirubin levels and length of hospital stay (time frame: from the beginning of the enrollment until 1 month after sedation anesthesia recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.