Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

China International Neuroscience Institution

Status and phase: Completed; Phase 3

Conditions: Nociceptive Pain; Inhalant Use; Analgesic Adverse Reaction

Treatments: Drug: 2 mg/kg/h Propofol; Drug: Sevoflurane; Drug: 5mg/kg/h Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03841812

CINI-ZYLX-201809-50

Details and patient eligibility

About

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

Full 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)

Enrollment: 146 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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146 participants in 2 patient groups

Propofol

Experimental group

Description:

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

Treatment:

Drug: 5mg/kg/h Propofol

Propofol & Sevoflurane

Experimental group

Description:

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

Treatment:

Drug: Sevoflurane

Drug: 2 mg/kg/h Propofol