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Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

Sponsor
China International Neuroscience Institution (Other)
Overall Status
Completed
CT.gov ID
NCT03841812
Collaborator
(none)
146
Enrollment
1
Location
2
Arms
5.4
Actual Duration (Months)
27.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Propofol

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

Drug: 5mg/kg/h Propofol
5mg/kg/h Propofol continuously infused during intre-operation
Other Names:
  • 5mg/kg/h Propofol Injection

    		•
    Experimental: Propofol & Sevoflurane

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

    Drug: Sevoflurane
    1% Sevoflurane continuously using during intre-operation.
    Other Names:
  • 1% Sevoflurane

    • Drug: 2 mg/kg/h Propofol
    2mg/kg/h Propofol continuously infused during intre-operation

    Outcome Measures

    Primary Outcome Measures

    1. qNOX change [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 Outcome Measures

    1. PACU duration [24 hours]

      Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients

    2. PONV difference between two groups [24 hours]

      postoperative nausea and vomiting ratio(PONV) difference between two groups. The more frequency of PONV, the worst comfortable outcome of the patients

    3. Post- operative pain difference between two groups [24 hours]

      Post- operative pain difference between two groups using VAS(Visual analogue rating) Score evaluation. Pain was assessed 24 h post operation using a 0-10 numeric pain rating scale (VAS scale), where zero meant no pain and 10 meant the worst imaginable pain.VAS score (Post-operation 24 h) (0-1 VAS indicate None pain; 2-5 VAS indicate Moderate pain; 6-10 VAS indicate severe pain)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • a history of alcohol or drug abuse

    • received central nervous system-active drugs

    • super obese as defined by a body mass index ≥40 kg/m2

    • conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics

    • previous head injury

    • neurologic

    • psychiatric disease

    • any disabling central nervous

    • cerebrovascular disease

    • using psychoactive

    • anti-convulsive medications at the time

    • unstable angina

    • manifested congestive heart failure

    • expected difficulty airway management

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xuanwu Hospital Beijing Beijing China 100053

    Sponsors and Collaborators

    • China International Neuroscience Institution

    Investigators

    • Principal Investigator: Ke Huang, MS, Xuanwu Hospital, Beijing

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    China International Neuroscience Institution
    ClinicalTrials.gov Identifier:
    NCT03841812
    Other Study ID Numbers:
    • CINI-ZYLX-201809-50
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Nociceptive Pain
    Propofol
    Sevoflurane

    Study Results

    No Results Posted as of Oct 14, 2020