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

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ClinicalTrials.gov Identifier: NCT03788447
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ji Eun Kim, Ajou University School of Medicine

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




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



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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

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 Recruiting
Suwon, Seoul, Korea, Republic of
Contact: Ji Eun Kim    82-31-219-5575    beye98@aumc.ac.kr   
Sponsors and Collaborators
Ajou University School of Medicine

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Responsible Party: Ji Eun Kim, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03788447     History of Changes
Other Study ID Numbers: MED-THE-18-410
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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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
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents