Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

Nociceptive Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841812
• Other study ID #: CINI-ZYLX-201809-50
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2020
• Source: China International Neuroscience Institution
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesic Adverse Reaction
• Inhalant Use
• Nociceptive Pain

Intervention

Drug:
• 5mg/kg/h Propofol
5mg/kg/h Propofol continuously infused during intre-operation
• Sevoflurane
1% Sevoflurane continuously using during intre-operation.
• 2 mg/kg/h Propofol
2mg/kg/h Propofol continuously infused during intre-operation

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PACU duration	Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients	24 hours
Secondary	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
Secondary	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