Back to resultsEffect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High end-tidal CO2
Low CO2 group
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- laparoscopic gastrectomy under general anesthesia
Exclusion Criteria:
- atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
High CO2 group
Low CO2 group
Arm Description
end tidal CO2 : 40-45 mmHg
end tidal CO2 : 30-35 mmHg
Outcomes
Primary Outcome Measures
total dose of remifentanil
total dose of remifentanil to maintain for surgical pleth index < 50
Secondary Outcome Measures
Full Information
NCT ID
NCT03788447
First Posted
December 24, 2018
Last Updated
January 6, 2021
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03788447
Brief Title
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia
Official Title
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the effect of pneumoperitoneum on remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic gastrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High CO2 group
Arm Type
Experimental
Arm Description
end tidal CO2 : 40-45 mmHg
Arm Title
Low CO2 group
Arm Type
Placebo Comparator
Arm Description
end tidal CO2 : 30-35 mmHg
Intervention Type
Other
Intervention Name(s)
High end-tidal CO2
Intervention Description
maintaining of end-tidal CO2 with the range of 40-45 mmHg
Intervention Type
Other
Intervention Name(s)
Low CO2 group
Intervention Description
maintaining of end-tidal CO2 with the range of 30-35 mmHg
Primary Outcome Measure Information:
Title
total dose of remifentanil
Description
total dose of remifentanil to maintain for surgical pleth index < 50
Time Frame
through study completion, an average of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
laparoscopic gastrectomy under general anesthesia
Exclusion Criteria:
atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
State/Province
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia
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