Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

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

Detailed Description
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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)

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

Conditions
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Nociceptive Pain, Analgesic Adverse Reaction, Inhalant Use

Intervention / Treatment
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* Drug: 5mg/kg/h Propofol
* Drug: Sevoflurane
* Drug: 2 mg/kg/h Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia. | Drug: 5mg/kg/h Propofol<br>* 5mg/kg/h Propofol continuously infused during intre-operation<br>* Other names: 5mg/kg/h Propofol Injection;|
| Experimental: Propofol & Sevoflurane<br>2mg/kg/h Propofol & 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia | Drug: Sevoflurane<br>* 1% Sevoflurane continuously using during intre-operation.<br>* Other names: 1% Sevoflurane;Drug: 2 mg/kg/h Propofol<br>* 2mg/kg/h Propofol continuously infused during intre-operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qNOX change | 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. | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU duration | Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients | 24 hours | 
| PONV difference between two groups | postoperative nausea and vomiting ratio(PONV) difference between two groups. The more frequency of PONV, the worst comfortable outcome of the patients | 24 hours | 
| Post- operative pain difference between two groups | 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) | 24 hours |