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Comparison of Analgesic Effect of Volatile Anesthetics

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ClinicalTrials.gov Identifier: NCT02830243
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Kyoungho Ryu, Kangbuk Samsung Hospital

Brief Summary:
The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Sevoflurane Drug: Desflurane Phase 3

Detailed Description:
Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Comparison of Analgesic Effect of Volatile Anesthetics Using Surgical Pleth Index
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : October 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: Sevoflurane
Anesthesia was maintained with sevoflurane.
Drug: Sevoflurane
End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
Other Name: SEVO

Experimental: Desflurane
Anesthesia was maintained with desflurane.
Drug: Desflurane
End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
Other Name: DES




Primary Outcome Measures :
  1. Remifentanil consumption (µg/kg/min) [ Time Frame: During the intraoperative period ]

Secondary Outcome Measures :
  1. Target effective site concentration of remifentanil (ng/ml) [ Time Frame: After at least 10 min of stable surgical pleth index values ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing balanced general anesthesia using volatile anesthetics and remifentanil
  • patients with american society of anesthesiologist physical status I, II
  • patients aged 19-65 years
  • patients obtaining written informed consent

Exclusion Criteria:

  • patients with a history of any psychiatric or neurological disease
  • patients who had received any medication affecting the central nervous system
  • patients who had received medication affecting the sympathetic or parasympathetic nervous systems
  • patients undergoing tracheal intubation for airway management
  • pregnant women

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): NCT02830243


Locations
Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
Principal Investigator: Kyoungho Ryu, M.D. Kangbuk Samsung Hospital

Responsible Party: Kyoungho Ryu, Clinical assistant professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02830243     History of Changes
Other Study ID Numbers: 2016-05-058
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Desflurane
Isoflurane
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General