An interventional study of Propofol and Low Remifentanil in General Anaesthesia, sponsored by Zhang Haopeng. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Zhang Haopeng · Not applicable, Interventional, and Diagnostic
The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.
eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.
Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation (5s, 50mA) and intubation. The concentration combinations include the electrical stimulation combination (effector chamber concentration random: remifentanil 0-3 ng/ml, propofol 3-5 ug/ml) and the intubation combination (effector chamber concentration random: remifentanil 3-5 ng/ml, propofol 3-5 ug/ml). All combinations were decided before operation. Every combination had a 5 min equilibration period, and the vital signs (Heart Rate, Blood pressure, any body movement) and BIS, eMAC will be recorded before and after the electrical stimulation and intubation. After this period, patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia, and regular anesthesia is executed. This study only records vital signs and BIS, eMAC during maintenance period of perioperative.
This is the only study on the registry with Zhang Haopeng as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
Drug: Propofol · Drug: Low Remifentanil · Procedure: tetanic electrical stimulation
During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
Drug: Propofol · Drug: Low Remifentanil · Procedure: tetanic electrical stimulation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
Drug: Propofol · Drug: Heigh Remifentanil · Procedure: Intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
Drug: Propofol · Drug: Heigh Remifentanil · Procedure: Intubation
Propofol (Random:3-5ug/ml)
Also known as: Propofol for tetanic electrical stimulation and intubation
Remifentanil (Random:0-3ug/ml)
Also known as: Remifentanil for tetanic electrical stimulation
Remifentanil (Random:3-5ug/ml)
Also known as: Remifentanil for intubation
Endotracheal intubation before surgery
tetanic electrical stimulation before surgery
Prediction probability of eMAC
Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween eMAC and the lable of response was calculated.
Time frame: 1 year
Prediction probability of BIS
Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween BIS and the lable of response was calculated.
Time frame: 1 year
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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