Pancreatic Cancer or Distal CBD Cancer
Conditions
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.
Interventions
DRUGDes (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).
DRUGTIVA (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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| score of QoR40 (Quality of Recovery 40) | 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 |
Secondary
| Measure | Time frame |
|---|---|
| score of QoR40 (Quality of Recovery 40) | post operative day #1 |
Countries
South Korea
Contacts
Primary ContactJeong-Rim LEE, Associate professor, MD. PhD
Backup ContactYoung-Eun JOE, MD, senior resident
Outcome results
None listed