- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03788447
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia
January 6, 2021 updated by: Ji Eun Kim, Ajou University School of Medicine
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
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 Locations
-
-
Seoul
-
Suwon, Seoul, Korea, Republic of
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
-
-
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
19 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- laparoscopic gastrectomy under general anesthesia
Exclusion Criteria:
- atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High CO2 group
end tidal CO2 : 40-45 mmHg
|
maintaining of end-tidal CO2 with the range of 40-45 mmHg
|
Placebo Comparator: Low CO2 group
end tidal CO2 : 30-35 mmHg
|
maintaining of end-tidal CO2 with the range of 30-35 mmHg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total dose of remifentanil
Time Frame: through study completion, an average of 2 hours
|
total dose of remifentanil to maintain for surgical pleth index < 50
|
through study completion, an average of 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 4, 2019
Primary Completion (Actual)
September 5, 2019
Study Completion (Actual)
September 5, 2019
Study Registration Dates
First Submitted
December 24, 2018
First Submitted That Met QC Criteria
December 25, 2018
First Posted (Actual)
December 27, 2018
Study Record Updates
Last Update Posted (Actual)
January 8, 2021
Last Update Submitted That Met QC Criteria
January 6, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJIRB-MED-THE-18-410
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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