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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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Yonsei University

Status

Unknown

Conditions

Pancreatic Cancer or Distal CBD Cancer

Treatments

Drug: TIVA (Total intravenous anesthesia with propofol and remifentanil)
Drug: Des (volatile anesthetic-desflurane)

Study type

Interventional

Funder types

Other

Identifiers

NCT03447691
4-2017-0662

Details and patient eligibility

About

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.

Enrollment

132 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

132 participants in 2 patient groups

DES Group
Experimental group
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).
Treatment:
Drug: Des (volatile anesthetic-desflurane)
TIVA Group
Active Comparator group
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).
Treatment:
Drug: TIVA (Total intravenous anesthesia with propofol and remifentanil)

Trial contacts and locations

1

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Central trial contact

Jeong-Rim LEE, Associate professor, MD. PhD; Young-Eun JOE, MD, senior resident

Data sourced from clinicaltrials.gov

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