Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

Phase 3

Completed

• Conditions: Nociceptive Pain; Analgesic Adverse Reaction; Inhalant Use
• Interventions: Drug: 5mg/kg/h Propofol; Drug: Sevoflurane; Drug: 2 mg/kg/h Propofol

• Registration Number: NCT03841812
• Lead Sponsor: China International Neuroscience Institution

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)

Study Timeline

• Study First Submitted: 2019-01-19
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Status Verified: 2020-01
• Study Start: 2020-01-20
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-10-10
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	5mg/kg/h Propofol	5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia.
Propofol & Sevoflurane	2 mg/kg/h Propofol	2mg/kg/h Propofol \& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia
Propofol & Sevoflurane	Sevoflurane	2mg/kg/h Propofol \& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PACU duration	24 hours	Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients
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
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)

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China