NCT03588429

Brief Summary

The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using 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 Jan 2020

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

First Submitted

Initial submission to the registry

July 6, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 9, 2024

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

July 6, 2018

Last Update Submit

April 8, 2024

Conditions

Keywords

SevofluraneIsoflurane

Outcome Measures

Primary Outcomes (1)

  • qCON index

    The hypnotic potency of volatile anesthetics was evaluated by qCON 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)

  • qNOX index

    the 10 min at steady-state anesthesia after endotracheal intubation

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Anesthesia was maintained with sevoflurane.

Drug: Sevoflurane

Isoflurane

EXPERIMENTAL

Anesthesia was maintained with isoflurane.

Drug: Isoflurane

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 isoflurane 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: ISO
Isoflurane

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 intubation
  • patients with american society of anesthesiologist physical status I, II
  • 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 supraglottic airway for airway management
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Cangzhou, Hebei, 061001, China

Location

MeSH Terms

Interventions

SevofluraneIsoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Ruizhao Lv, M.D

    Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2018

First Posted

July 17, 2018

Study Start

January 1, 2020

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

April 9, 2024

Record last verified: 2018-08

Locations