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Clinical Trials/NCT03841812
NCT03841812
Completed
Phase 3

Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)

China International Neuroscience Institution1 site in 1 country146 target enrollmentJanuary 20, 2020

Overview

Phase
Phase 3
Intervention
5mg/kg/h Propofol
Conditions
Nociceptive Pain
Sponsor
China International Neuroscience Institution
Enrollment
146
Locations
1
Primary Endpoint
qNOX change
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)

Detailed Description

1. Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency. 2. propofol was traditional sedation reagent. 3. index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)

Registry
clinicaltrials.gov
Start Date
January 20, 2020
End Date
July 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
China International Neuroscience Institution
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants were aged 18-65 years old,
  • American Society of Anesthesiologists (ASA) physical status I, II or III
  • scheduled to have urological surgery(would last longer than 1 h)
  • requiring general anesthesia.
  • Exclusion criteria:
  • refused to participate in this study;
  • Unable to communicate normally because of consciousness alterations;
  • a history of allergy to opioids
  • contraindications to inhalational anesthesia
  • a family history of malignant hyperthermia

Exclusion Criteria

  • Not provided

Arms & Interventions

Propofol

5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia.

Intervention: 5mg/kg/h Propofol

Propofol & Sevoflurane

2mg/kg/h Propofol \& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia

Intervention: Sevoflurane

Propofol & Sevoflurane

2mg/kg/h Propofol \& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia

Intervention: 2 mg/kg/h Propofol

Outcomes

Primary Outcomes

qNOX change

Time Frame: during operation

Nociception of index (qNOX) difference between two groups. The nociception index (NOX) derived from electroencephalogram (EEG) signals has been proposed as a noninvasive guide to indicate anesthesia depth. The neurological processing of noxious stimuli is defined as nociception. NOX ranges from 0-99, and the lower the index, the deeper the state of analgesia. NOX lower than 20 represents deep analgesia, and higher than 80 represents inadequate analgesia.

Secondary Outcomes

  • PACU duration(24 hours)
  • PONV difference between two groups(24 hours)
  • Post- operative pain difference between two groups(24 hours)

Study Sites (1)

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