Pancreatic Cancer or Distal CBD CancerNCT03447691
Comparison Between Volatile Anesthetic-desflurane and Total Intravenous Anesthesia With Propofol and Remifentanil on Early Recovery Quality and Long Term Prognosis of Patients Undergoing Pancreatic Cancer and Common Bile Duct Cancer Surgery
A study testing Des (volatile anesthetic-desflurane) and TIVA (Total intravenous anesthesia with propofol and remifentanil) in people with Pancreatic Cancer or Distal CBD Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Cancer or Distal CBD Cancer
- What is being tested?
- Des (volatile anesthetic-desflurane) and TIVA (Total intravenous anesthesia with propofol and remifentanil)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Aug 2017to 28 Aug 2022
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA class I-III who are scheduled to undergo general anesthesia and who are diagnosed with pancreatic cancer or common bile duct cancer and who are scheduled for PPPD or distal pancreatectomy
- patients who voluntarily agree to participate the clinical study after fully informed and understood about the study
Who cannot join
- there was distant metastasis at the time of diagnosis
- history of drug adverse reaction or use of opioid or sedative drugs before the surgery
- patients who can not communicate enough to answer the survey
- obesity patients over BMI 30
- patient who are expected to maintain ventilator care on the first day of post operation due to the difficult to extubation right after the surgery
- patients who have inappropriate reasons to participate in clinical research
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
Seoul, 120-752
Jeong-Rim LEE, MD, PhD, 02-2227-3840, MANYA@yuhs.ac
About this study
Investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy.
- Conditions
- Pancreatic Cancer or Distal CBD Cancer
- Being tested
- Des (volatile anesthetic-desflurane), TIVA (Total intravenous anesthesia with propofol and remifentanil)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Des (volatile anesthetic-desflurane)Drug
Inducing unconciouness with 1.5 to 2 mg/kg of propofol, Intubation is performed 3 minutes after administration of remifentanil 1-2 mcg / kg and rocuronium 0.6 mg / kg. Desflurane concentration is maintained 3-7% (0.7-1.1 MAC) and remifentanil continuous infusion (0.02-0.2 mcg / kg / min).
TIVA (Total intravenous anesthesia with propofol and remifentanil)Drug
TIVA group is administered with intravenous anesthetic using commercial target controlled infusion (TCI) pump. Anesthesia is induced and maintained with 2-6 mcg / ml propofol and 2-6 ng / ml remifentanil, which are converted to the effect site concentration. After administrating rocuronium 0.6mg/kg, intubation is performed.
| Study group | Role | What they receive |
|---|---|---|
| DES Group | Experimental | Desflurane will be administered via tracheal intubation tube at the level of 0.7-1.1 MAC. Remifentanil will be maintained intravenously by continuous infusion rate of 0.01-0.1 mcg / kg / min
DES Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate). Receives: Drug: Des (volatile anesthetic-desflurane) |
| TIVA Group | Active comparator | Propofol and remifentanil will be administered via intravenous, using an infusion pump capable of effect site target controlled infusion.
TIVA Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate). Receives: Drug: TIVA (Total intravenous anesthesia with propofol and remifentanil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of QoR40 (Quality of Recovery 40)
The QoR-40 consists of a total of 40 questionnaires divided into five categories, it is considered to be the most appropriate index to measure the patient's integrated post operation recovery. Our primary outcome is the score of QoR-40 on the third day after surgery
Measured: post operative day #3
Secondary outcomes (2)
score of QoR40 (Quality of Recovery 40)
Measured: post operative day #1
score of QoR40 (Quality of Recovery 40)
Measured: post operative day #7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start27 Aug 2017
- Primary completion28 Aug 2022 (estimated)
- Study completion28 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer or Distal CBD CancerStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447691
- Sponsor's protocol ID
- 4-2017-0662
- Status last verified
- Jan 2019
- First submitted
- 11 Feb 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joe YE, Kang CM, Lee HM, Kim KJ, Hwang HK, Lee JR. Quality of Recovery of Patients Who Underwent Curative Pancreatectomy: Comparison of Total Intravenous Anesthesia Versus Inhalation Anesthesia Using the QOR-40 Questionnaire. World J Surg. 2021 Aug;45(8):2581-2590. doi: 10.1007/s00268-021-06117-0. Epub 2021 Apr 21.
PubMed 33881579
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Volatile Anesthetic-desflurane and Total Intravenous Anesthesia With Propofol and Remifentanil on Early Recovery Quality and Long Term Prognosis of Patients Undergoing Pancreatic Cancer and Common Bile Duct Cancer Surgery
- ClinicalTrials.gov ID
- NCT03447691
- Acronym / sponsor ID
- 4-2017-0662
- Conditions
- Pancreatic Cancer or Distal CBD Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 Aug 2017 (actual)
- Primary completion
- 28 Aug 2022 (estimated)
- Study completion
- 28 Aug 2022 (estimated)
- First posted
- 27 Feb 2018 (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.
Investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DES Group | Experimental | Drug: Des (volatile anesthetic-desflurane)Desflurane will be administered via tracheal intubation tube at the level of 0.7-1.1 MAC. Remifentanil will be maintained intravenously by continuous infusion rate of 0.01-0.1 mcg / kg / min DES Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate). |
| TIVA Group | Active comparator | Drug: TIVA (Total intravenous anesthesia with propofol and remifentanil)Propofol and remifentanil will be administered via intravenous, using an infusion pump capable of effect site target controlled infusion. TIVA Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with ASA class I-III who are scheduled to undergo general anesthesia and who are diagnosed with pancreatic cancer or common bile duct cancer and who are scheduled for PPPD or distal pancreatectomy
- patients who voluntarily agree to participate the clinical study after fully informed and understood about the study
Key exclusion criteria (6 listed)
- there was distant metastasis at the time of diagnosis
- history of drug adverse reaction or use of opioid or sedative drugs before the surgery
- patients who can not communicate enough to answer the survey
- obesity patients over BMI 30
- patient who are expected to maintain ventilator care on the first day of post operation due to the difficult to extubation right after the surgery
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 |
|---|---|---|
| Des (volatile anesthetic-desflurane)Inducing unconciouness with 1.5 to 2 mg/kg of propofol, Intubation is performed 3 minutes after administration of remifentanil 1-2 mcg / kg and rocuronium 0.6 mg / kg. Desflurane concentration is maintained 3-7% (0.7-1.1 MAC) and remifentanil continuous infusion (0.02-0.2 mcg / kg / min). | Drug | DES Group |
| TIVA (Total intravenous anesthesia with propofol and remifentanil)TIVA group is administered with intravenous anesthetic using commercial target controlled infusion (TCI) pump. Anesthesia is induced and maintained with 2-6 mcg / ml propofol and 2-6 ng / ml remifentanil, which are converted to the effect site concentration. After administrating rocuronium 0.6mg/kg, intubation is performed. | Drug | TIVA Group |
Primary outcome
score of QoR40 (Quality of Recovery 40)
Time frame: post operative day #3
The QoR-40 consists of a total of 40 questionnaires divided into five categories, it is considered to be the most appropriate index to measure the patient's integrated post operation recovery. Our primary outcome is the score of QoR-40 on the third day after surgery
2 secondary outcomes
score of QoR40 (Quality of Recovery 40)
Time frame: post operative day #1
score of QoR40 (Quality of Recovery 40)
Time frame: post operative day #7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 33881579Joe YE, Kang CM, Lee HM, Kim KJ, Hwang HK, Lee JR. Quality of Recovery of Patients Who Underwent Curative Pancreatectomy: Comparison of Total Intravenous Anesthesia Versus Inhalation Anesthesia Using the QOR-40 Questionnaire. World J Surg. 2021 Aug;45(8):2581-2590. doi: 10.1007/s00268-021-06117-0. Epub 2021 Apr 21.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Des (volatile anesthetic-desflurane) and TIVA (Total intravenous anesthesia with propofol and remifentanil) in people with Pancreatic Cancer or Distal CBD Cancer, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 6 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 11 Jan 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Rim LEE, Associate professor, MD. PhD (82-2-2227-3840, leejeongrim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of QoR40 (Quality of Recovery 40) (time frame: post operative day #3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447691, which also lists 1 linked publication.
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 11 Jan 2019.