Back to resultsComparison 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
Primary Purpose
Pancreatic Cancer or Distal CBD Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Des (volatile anesthetic-desflurane)
TIVA (Total intravenous anesthesia with propofol and remifentanil)
Sponsored by
About this trial
This is an interventional other trial for Pancreatic Cancer or Distal CBD Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DES Group
TIVA Group
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
score of QoR40 (Quality of Recovery 40)
score of QoR40 (Quality of Recovery 40)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03447691
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2017 (Actual)
Primary Completion Date
August 28, 2022 (Anticipated)
Study Completion Date
August 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer or Distal CBD Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The investigator who research the QoR-40 questionnaire before and after the surgery will not know which group the patient is assigned to.
Because of the difference in anesthesia method, it is impossible to apply blindness to an anesthesiologist practicing anesthesia. Thus, the anesthesiologist will maintain anesthesia with the same target in both groups. (anesthesia depth, hemodynamic status and pain control)
Blind is released to investigator and outcomes assessor after completion of QoR-40 questionnaire.
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DES Group
Arm Type
Experimental
Arm Description
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).
Arm Title
TIVA Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Des (volatile anesthetic-desflurane)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
TIVA (Total intravenous anesthesia with propofol and remifentanil)
Intervention Description
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.
Primary Outcome Measure Information:
Title
score of QoR40 (Quality of Recovery 40)
Description
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
Time Frame
post operative day #3
Secondary Outcome Measure Information:
Title
score of QoR40 (Quality of Recovery 40)
Time Frame
post operative day #1
Title
score of QoR40 (Quality of Recovery 40)
Time Frame
post operative day #7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Rim LEE, Associate professor, MD. PhD
Phone
82-2-2227-3840
Email
leejeongrim@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Eun JOE, MD, senior resident
Phone
82-2-2227-3840
Email
joeye@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Rim LEE, MD, PhD
Phone
02-2227-3840
Email
MANYA@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33881579
Citation
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.
Results Reference
derived
Learn more about this trial
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
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