CClinicalTrials.gg
CompletedNCT03588429Updated Apr 9, 2024

The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

A Phase 3 interventional study of Sevoflurane and Isoflurane in Anesthesia, sponsored by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine. Completed at 1 site in China. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Anesthetic agents vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there is no study that demonstrate the difference between analgesic potency of volatile anesthetics. 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.

02

Conditions studied

  • Anesthesia

Keywords

  • Sevoflurane
  • Isoflurane
03

In context

Lead sponsor

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing general anesthesia using volatile anesthetics and intubation
  • patients with american society of anesthesiologist physical status I, II
  • patients obtaining written informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Sevoflurane

    Anesthesia was maintained with sevoflurane.

    Drug: Sevoflurane

  • Experimental
    Isoflurane

    Anesthesia was maintained with isoflurane.

    Drug: Isoflurane

Interventions

  • DrugSevoflurane

    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

  • DrugIsoflurane

    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

06

What researchers measure

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).

    Time frame: the 10 min at steady-state anesthesia after endotracheal intubation

Secondary outcomes

  1. qNOX index

    The analgesic potency of volatile anesthetics was evaluated by qNOX index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).

    Time frame: the 10 min at steady-state anesthesia after endotracheal intubation

07

Study locations

1 site
  • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
    Cangzhou, Hebei 061001, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03588429
Lead sponsor
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Responsible party
Sponsor
First posted
Jul 17, 2018
Start date
Jan 1, 2020
Primary completion
Aug 1, 2020
Completion
Dec 1, 2020
Last update
Apr 9, 2024

Study contacts

Ruizhao Lv, M.D
principal investigator · Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion