The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: Isoflurane; Drug: Sevoflurane

• Registration Number: NCT03588429
• Lead Sponsor: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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.

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.

Study Timeline

• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-17
• Status Verified: 2018-08
• Study Start: 2020-01-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-12-01
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isoflurane	Isoflurane	Anesthesia was maintained with isoflurane.
Sevoflurane	Sevoflurane	Anesthesia was maintained with sevoflurane.

Primary Outcome Measures

Name	Time	Method
qCON index	the 10 min at steady-state anesthesia after endotracheal intubation	The hypnotic potency of volatile anesthetics was evaluated by qCON index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).

Secondary Outcome Measures

Name	Time	Method
qNOX index	the 10 min at steady-state anesthesia after endotracheal intubation	The analgesic potency of volatile anesthetics was evaluated by qNOX index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).

Trial Locations

Locations (1)

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine; 🇨🇳 Cangzhou, Hebei, China