Percutaneous Transhepatic CholangiographyNCT03103672
Total Intravenous Anesthesia in Percutaneous Transhepatic Cholangiography
An observational study of Percutaneous Transhepatic Cholangiography, run by Inonu University.
Trial summary
Percutaneous transhepatic cholangiography is a disturbing procedure for patients. TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Percutaneous Transhepatic Cholangiography
- What is being tested?
- Percutaneous transhepatic cholangiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2017to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing percutaneous transhepatic cholangiography
Who may be able to join
- Adult patients undergoing percutaneous transhepatic cholangiography with general anesthesia
Who cannot join
- Essential data were missing
- Patient participating in other research projects
- Drug allergy
- Anesthetic complication story
About this study
Official title: Comparison of Inhalation Anesthesia and Total Intravenous Anesthesia in Percutaneous Transhepatic Cholangiography
Percutaneous transhepatic cholangiography is a disturbing procedure for patients.
TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia.
Read the detailed description
Percutaneous transhepatic cholangiography is a disturbing procedure for patients. Especially pain at the time of dilation can be a serious problem. These situations may be required local anesthetics, intravenous narcotics and sedatives or general anesthesia (1).
TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile (2).
The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia and Determine their advantages and disadvantages.
- Michael J. Lee, Peter R. Mueller, Sanjay Saini, Peter F. Hahn, Stewen L. Dawson. Percutaneous Dilatation of Benign Biliary Strictures: Single-Season Therapy with General Anesthesia. AJR: 157, December 1991: 1263-1266
- Xiaoqian Deng, Tao Zhu. Clinical comparison of propofol-remifentanil TCI with sevoflurane induction / maintenance anesthesia in laparoscopic cholecystectomy. Pak J Med Sci 2014 Vol. 30 No. 5: 1017-1021
- Being tested
- Percutaneous transhepatic cholangiography
- Keywords
- quality of anesthesia, reduce recovery time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transhepatic cholangiographyProcedure or surgery
Also called PTC
Percutaneous transhepatic cholangiography (PTC) can be performed via the right midaxillary approach, though a subxiphoid approach is occasionally needed
| Study group | Role | What they receive |
|---|---|---|
| Groupe I | Patients who will receive inhalation anesthesia Receives: Procedure: Percutaneous transhepatic cholangiography | |
| Groupe 2 | Patients who will receive total intravenous anesthesia Receives: Procedure: Percutaneous transhepatic cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time from anesthesia
Time for Modified Aldrete Score 9 and over
Measured: up to postoperative 1 hours
Secondary outcomes (2)
Heart rate
Every 5 minutes during the process
Measured: up to postoperative 1 hours
Mean blood pressure
Every 5 minutes during the process
Measured: up to postoperative 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start2 Jan 2017
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Transhepatic CholangiographyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Ziya ÇOLAK, Inonu University
- Investigators
- Yusuf Z Çolak, MD, Principal investigator, Department of Anesthesia, İnonu Univercity, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103672
- Sponsor's protocol ID
- 2016/101
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inhalation Anesthesia and Total Intravenous Anesthesia in Percutaneous Transhepatic Cholangiography
- ClinicalTrials.gov ID
- NCT03103672
- Acronym / sponsor ID
- 2016/101
- Keywords
- quality of anesthesia, reduce recovery time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Apr 2017 (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.
Percutaneous transhepatic cholangiography is a disturbing procedure for patients.
TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia.
Detailed description
Percutaneous transhepatic cholangiography is a disturbing procedure for patients. Especially pain at the time of dilation can be a serious problem. These situations may be required local anesthetics, intravenous narcotics and sedatives or general anesthesia (1).
TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile (2).
The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia and Determine their advantages and disadvantages.
- Michael J. Lee, Peter R. Mueller, Sanjay Saini, Peter F. Hahn, Stewen L. Dawson. Percutaneous Dilatation of Benign Biliary Strictures: Single-Season Therapy with General Anesthesia. AJR: 157, December 1991: 1263-1266
- Xiaoqian Deng, Tao Zhu. Clinical comparison of propofol-remifentanil TCI with sevoflurane induction / maintenance anesthesia in laparoscopic cholecystectomy. Pak J Med Sci 2014 Vol. 30 No. 5: 1017-1021
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groupe I | – | Procedure: Percutaneous transhepatic cholangiographyPatients who will receive inhalation anesthesia |
| Groupe 2 | – | Procedure: Percutaneous transhepatic cholangiographyPatients who will receive total intravenous anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing percutaneous transhepatic cholangiography
Key inclusion criteria (1 listed)
- Adult patients undergoing percutaneous transhepatic cholangiography with general anesthesia
Key exclusion criteria (4 listed)
- Essential data were missing
- Patient participating in other research projects
- Drug allergy
- Anesthetic complication story
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous transhepatic cholangiographyAlso: PTCPercutaneous transhepatic cholangiography (PTC) can be performed via the right midaxillary approach, though a subxiphoid approach is occasionally needed | Procedure or surgery | Groupe 2, Groupe I |
Primary outcome
Recovery time from anesthesia
Time frame: up to postoperative 1 hours
Time for Modified Aldrete Score 9 and over
2 secondary outcomes
Heart rate
Time frame: up to postoperative 1 hours
Mean blood pressure
Time frame: up to postoperative 1 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Yusuf Z Çolak, MD principal investigator
Department of Anesthesia, İnonu Univercity, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Transhepatic Cholangiography, run by Inonu University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Recovery time from anesthesia (time frame: up to postoperative 1 hours). 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 5 Apr 2022.