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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03447691
Other study ID # 4-2017-0662
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 27, 2017
Est. completion date August 28, 2022

Study information

Verified date January 2019
Source Yonsei University
Contact Jeong-Rim LEE, Associate professor, MD. PhD
Phone 82-2-2227-3840
Email leejeongrim@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 132
Est. completion date August 28, 2022
Est. primary completion date August 28, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary score of QoR40 (Quality of Recovery 40) 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 score of QoR40 (Quality of Recovery 40) post operative day #1
Secondary score of QoR40 (Quality of Recovery 40) post operative day #7