NCT02609802

Brief Summary

The aim of this clinical trial is to evaluate the difference of analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using a surgical pleth index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2016

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

November 18, 2015

Last Update Submit

November 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analgesic potency of volatile anesthetics

    The analgesic potency was evaluated by surgical pleth index value

    the first 60 min of maintaining a steady state 1 MAC of volatile agents

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 arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.

Also known as: SEVO
Sevoflurane

Anesthesia was maintained with desflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.

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 arthroscopic shoulder surgery
  • 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 who have not received interscalene approach brachial plexus block (refusal or failure)
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

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

November 18, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

July 28, 2016

Study Completion

July 28, 2016

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations