NCT02698514

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2016

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

February 22, 2016

Last Update Submit

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

EXPERIMENTAL

Anesthesia was maintained with sevoflurane.

Drug: Sevoflurane

Desflurane

EXPERIMENTAL

Anesthesia was maintained with desflurane.

Drug: 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).

Also known as: SEVO
Sevoflurane

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).

Also known as: DES
Desflurane

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Kyoungho Ryu, M.D.

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

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

Locations