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NCT Number: NCT03841812

Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

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

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Key information

Conditions

Nociceptive Pain Analgesic Adverse Reaction Inhalant Use Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

About this study

  • 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.
  • propofol was traditional sedation reagent.
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5mg/kg/h Propofol

Drug

5mg/kg/h Propofol continuously infused during intre-operation

Other names: 5mg/kg/h Propofol Injection

Sevoflurane

Drug

1% Sevoflurane continuously using during intre-operation.

Other names: 1% Sevoflurane

2 mg/kg/h Propofol

Drug

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

Primary outcomes

  1. 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

  1. PACU duration

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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