Elective Surgery, Noxious Stimuli, Target Controlled Infusion (TCI), Tracheal Intubation Stimulation
Conditions
Keywords
ciprofol, remifentanil, effective concentration, tracheal intubation stimulation, qNOX index
Brief summary
1. The combined induction of intubation with propofol and remifentanil is widely used in clinical anesthesia, primarily through a single intravenous injection. Target-controlled infusion (TCI) technology, which combines pharmacology with clinical practice, offers a more stable and precise infusion mode; 2. This project aims to explore the half-effective concentration (EC50) of propofol combined with remifentanil for inhibiting tracheal intubation stimulation through a sequential approach under the monitoring of qNOX pain index.
Detailed description
Patients undergoing elective surgery, aged 19 to 55 years, with ASA I or II, were selected for a sequential trial in two stages: 1. In the first stage, induction dose of ciprofol was fixed at 0.4 mg/kg, and the EC50 and EC95 (exploratory) of remifentanil were measured. 2. In the second stage, the concentration of remifentanil was fixed, and the EC50 and EC95 (exploratory) of ciprofol were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method. 3. Additionally, the effectiveness of the qNOX index in guiding tracheal intubation stimulation was evaluated by analyzing the receiver operating characteristic (ROC) curves.
Interventions
DRUGCipofol combined with remifentanil administered via target-controlled infusion
Cipofol combined with remifentanil administered via target-controlled infusion for inhibiting tracheal intubation stimulation in adults under qNOX pain index monitoring.
Sponsors
Guangzhou General Hospital of Guangzhou Military Command
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
Sequential method: Adjust the drug concentration for the next patient based on whether the previous case meets the conditions for inhibiting intubation stimulation
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective surgery and require general anesthesia with single-lumen endotracheal intubation: ASA physical status I-II, aged between 18 and 55 years, with a body mass index (BMI) between 18.5 and 30 kg/m2
Exclusion criteria
* 1.Emergency surgery patients, children, pregnant women; 2.Patients with unstable vital signs: such as blood pressure, heart rate, and blood oxygen saturation exceeding the safe range; 3.Patients with craniocerebral trauma or central nervous system lesions; 4.Patients who are allergic to the studied anesthetic drugs, or have recently received other experimental drugs, major surgery, radiotherapy, or chemotherapy; 5.Patients who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Half-effective concentration | Calculated using SPSS software based on the TCI target concentration set during anesthesia induction (the fixed value of the inducing dose does not change over time). |
| Heart rate | 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). |
| blood pressure | 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). |
| CCS score (intubation score) | within 1 min while intubation (satisfactory intubation conditions simultaneously meet: visible laryngoscope exposure, no vocal cord movement, no coughing, relaxed jaw, no limb movement; otherwise, it is considered unsatisfactory intubation conditions) |
Secondary
| Measure | Time frame |
|---|---|
| BIS index | 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). |
| qNOX index | 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). |
| EMG index | 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage). |
Countries
China
Outcome results
None listed