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Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788447
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ji Eun Kim, Ajou University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Other: High end-tidal CO2 Other: Low CO2 group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy
Actual Study Start Date : June 4, 2019
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : September 5, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: High CO2 group
end tidal CO2 : 40-45 mmHg
 Other: High end-tidal CO2
maintaining of end-tidal CO2 with the range of 40-45 mmHg
Placebo Comparator: Low CO2 group
end tidal CO2 : 30-35 mmHg
 Other: Low CO2 group
maintaining of end-tidal CO2 with the range of 30-35 mmHg


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

  • atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Contacts and Locations
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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): NCT03788447


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoul, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
More Information
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Responsible Party: Ji Eun Kim, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03788447    
Other Study ID Numbers: AJIRB-MED-THE-18-410
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021

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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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Pneumoperitoneum
Digestive System Diseases
Peritoneal Diseases