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

January 10, 2019 updated by: Yonsei University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeong-Rim LEE, Associate professor, MD. PhD
  • Phone Number: 82-2-2227-3840
  • Email: leejeongrim@gmail.com

Study Contact Backup

  • Name: Young-Eun JOE, MD, senior resident
  • Phone Number: 82-2-2227-3840
  • Email: joeye@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
        • Contact:
          • Jeong-Rim LEE, MD, PhD
          • Phone Number: 02-2227-3840
          • Email: MANYA@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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).
Active Comparator: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post operative day #3

Secondary Outcome Measures

Outcome Measure
Time Frame
score of QoR40 (Quality of Recovery 40)
Time Frame: post operative day #1
post operative day #1
score of QoR40 (Quality of Recovery 40)
Time Frame: post operative day #7
post operative day #7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2017

Primary Completion (Anticipated)

August 28, 2022

Study Completion (Anticipated)

August 28, 2022

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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