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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-27

Study Completion Date

2022-08-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer or Distal CBD Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

* 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.

Study Groups

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DES Group

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).

Group Type EXPERIMENTAL

Des (volatile anesthetic-desflurane)

Intervention Type 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 Group

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).

Group Type ACTIVE_COMPARATOR

TIVA (Total intravenous anesthesia with propofol and remifentanil)

Intervention Type 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.

Interventions

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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).

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No