Comparison of Analgesic Effect of Volatile Anesthetics
The Comparison of Analgesic Effect of Volatile Anesthetics Using Surgical Pleth Index
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedStudy Start
First participant enrolled
July 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2016
CompletedMay 15, 2018
May 1, 2018
3 months
July 9, 2016
May 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Remifentanil consumption (µg/kg/min)
During the intraoperative period
Secondary Outcomes (1)
Target effective site concentration of remifentanil (ng/ml)
After at least 10 min of stable surgical pleth index values
Study Arms (2)
Sevoflurane
EXPERIMENTALAnesthesia was maintained with sevoflurane.
Desflurane
EXPERIMENTALAnesthesia was maintained with desflurane.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Related Publications (1)
Ryu KH, Kim JA, Ko DC, Lee SH, Choi WJ. Desflurane reduces intraoperative remifentanil requirements more than sevoflurane: comparison using surgical pleth index-guided analgesia. Br J Anaesth. 2018 Nov;121(5):1115-1122. doi: 10.1016/j.bja.2018.05.064. Epub 2018 Jul 4.
PMID: 30336856DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyoungho Ryu, M.D.
Kangbuk Samsung Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
July 9, 2016
First Posted
July 12, 2016
Study Start
July 12, 2016
Primary Completion
October 5, 2016
Study Completion
October 8, 2016
Last Updated
May 15, 2018
Record last verified: 2018-05