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Trial record 63 of 170 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

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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ClinicalTrials.gov Identifier: NCT03447691
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer or Distal CBD Cancer Drug: Des (volatile anesthetic-desflurane) Drug: TIVA (Total intravenous anesthesia with propofol and remifentanil) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Primary Purpose: Other
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
Actual Study Start Date : August 27, 2017
Estimated Primary Completion Date : August 28, 2022
Estimated Study Completion Date : August 28, 2022


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. score of QoR40 (Quality of Recovery 40) [ Time Frame: post operative day #1 ]
  2. score of QoR40 (Quality of Recovery 40) [ Time Frame: post operative day #7 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447691


Contacts
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Contact: Jeong-Rim LEE, Associate professor, MD. PhD 82-2-2227-3840 leejeongrim@gmail.com
Contact: Young-Eun JOE, MD, senior resident 82-2-2227-3840 joeye@yuhs.ac

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

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03447691     History of Changes
Other Study ID Numbers: 4-2017-0662
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholangiocarcinoma
Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anesthetics
Propofol
Desflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents