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

  • Korea, Republic of
    • 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
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

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.

Sponsor

Ajou University School of Medicine

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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