Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

NCT ID: NCT03841812

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2020-07-01

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)

Conditions

Nociceptive Pain; Analgesic Adverse Reaction; Inhalant Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Propofol

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

Group Type: EXPERIMENTAL

5mg/kg/h Propofol

Intervention Type: DRUG

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

Propofol & Sevoflurane

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

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

1% Sevoflurane continuously using during intre-operation.

2 mg/kg/h Propofol

Intervention Type: DRUG

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

Interventions

5mg/kg/h Propofol

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

Intervention Type: DRUG

Sevoflurane

1% Sevoflurane continuously using during intre-operation.

Intervention Type: DRUG

2 mg/kg/h Propofol

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

Intervention Type: DRUG

Other Intervention Names

5mg/kg/h Propofol Injection; 1% Sevoflurane

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China International Neuroscience Institution

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ke Huang, MS

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CINI-ZYLX-201809-50

Identifier Type: -

Identifier Source: org_study_id