- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03841812
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol
October 10, 2020 updated by: China International Neuroscience Institution
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)
This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
- 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)
Study Type
Interventional
Enrollment (Actual)
146
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Xuanwu Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Propofol
5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia.
|
5mg/kg/h Propofol continuously infused during intre-operation
Other Names:
|
Experimental: Propofol & Sevoflurane
2mg/kg/h Propofol & 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia
|
1% Sevoflurane continuously using during intre-operation.
Other Names:
2mg/kg/h Propofol continuously infused during intre-operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
qNOX change
Time Frame: 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.
|
during operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PACU duration
Time Frame: 24 hours
|
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
Time Frame: 24 hours
|
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
Time Frame: 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)
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ke Huang, MS, Xuanwu Hospital, Beijing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2020
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
July 1, 2020
Study Registration Dates
First Submitted
January 19, 2019
First Submitted That Met QC Criteria
February 13, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
October 14, 2020
Last Update Submitted That Met QC Criteria
October 10, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CINI-ZYLX-201809-50
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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