General Anesthetic Drug Adverse Reaction
Conditions
Brief summary
In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or Tegilerdine. The cough was graded based on the frequency and duration: Grade I, no cough; Grade II, a single mild cough; Grade III, multiple coughs with duration \<1 second; Grade IV, continuous coughing with a duration \>15 seconds.
Detailed description
Using a computer-generated randomized number table, patients were divided into two groups: the experimental group receiving Tiliglitidine (T group) at 20-50ug/kg, and the control group receiving Sufentanil (S group) at 0.2-0.4 μg/kg. After patients arrived in the operating room, routine monitoring including non-invasive blood pressure, electrocardiogram, and oxygen saturation was performed, and intravenous access was established. Patients were oxygenated and given the study drug before anesthesia induction. No other drugs were administered to the patients before giving the study drug. During anesthesia induction, patients received intravenous injection of Tiliglitide or Sufentanil according to their group. The severity of coughing was graded based on the number of coughing episodes: graded by the number and duration of coughs: Grade I, no cough, breathing regular; Grade II, a single mild cough; Grade III, multiple coughs, lasting less than 15 seconds; Grade IV, continuous coughs, lasting more than 15 seconds.
Interventions
DRUGTegilerdine
Inject Tegilerdine in the induction of general anesthesia
DRUGSufentanil
Inject Sufentanil in the induction of general anesthesia
Sponsors
The First People's Hospital of Lianyungang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30; 2. ASA grade I \~ III; 3. Scheduled elective surgery under general anesthesia with tracheal intubation.
Exclusion criteria
1. Patients with chronic cough (cough lasting \>8 weeks) or asthma; 2. Patients with a history of allergy to the drugs used during the study; 3. Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of choking cough response | 2 minutes after administration | Two minutes after administration of the study drugs (Tegilerdine/Sufentanil), any clear coughing action is considered an 'occurrence'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grading of choking and coughing response | 2 minutes after administration | Grading based on the number and duration of coughs: Grade I, no coughing, breathing is even; Grade II, a single mild cough; Grade III, multiple coughs lasting less than 15 seconds; Grade IV, continuous coughing lasting more than 15 seconds |
| Blood pressure | before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4） | Blood pressure before and after administration, and before and after intubation |
| Heart rate | before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4） | heart rate before and after administration, and before and after intubation |
| Adverse reaction | 2 minutes after administration | such as respiratory depression, vomiting, nausea, itching, etc.) |
Countries
China
Contacts
CONTACTXiaobao Zhang, Doctor
STUDY_DIRECTORXiaobao Zhang, Doctor
Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital
Outcome results
None listed