The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
1 other identifier
interventional
90
1 country
1
Brief Summary
The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.
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 Feb 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
Study Start
First participant enrolled
February 16, 2016
CompletedFirst Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2016
CompletedMay 8, 2018
May 1, 2018
5 months
February 22, 2016
May 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical pleth index
The analgesic potency of volatile anesthetics was evaluated by surgical pleth index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).
the 10 min at steady-state anesthesia after endotracheal intubation
Secondary Outcomes (1)
Bispectral index
the 10 min at steady-state anesthesia after endotracheal intubation
Study Arms (2)
Sevoflurane
EXPERIMENTALAnesthesia was maintained with sevoflurane.
Desflurane
EXPERIMENTALAnesthesia was maintained with desflurane.
Interventions
Anesthesia was maintained with sevoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Anesthesia was maintained with desflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Eligibility Criteria
You may qualify if:
- patients undergoing general anesthesia using volatile anesthetics and supraglottic airway (I-gel™)
- 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
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
February 22, 2016
First Posted
March 3, 2016
Study Start
February 16, 2016
Primary Completion
July 13, 2016
Study Completion
July 13, 2016
Last Updated
May 8, 2018
Record last verified: 2018-05