postoperative sore throat
Conditions
Interventions
one:1% tetracaine hydrochloride
two:0.9% normal saline
Sponsors
Southern Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Voluntary signing of informed consent; (2) Patients undergoing elective surgery under general anesthesia for tracheal intubation, the expected duration of surgery lasts 2 to 4 hours. (3) Aged >= 18 and <= 65 years; gender is not limited. (4) 18kg/m2 <= BMI <= 30kg/m2. (5) The ASA classification is I~II. (6) All patients underwent video laryngoscopy before tracheal intubation to determine possible undiagnosed vocal cord lesions. (7) Patients have a full understanding of the purpose and significance of this trial and volunteer to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: (1) Patients with general anesthesia and tracheal intubation within 7 days before randomization; (2) Patients with throat and vocal cord surgery; (3) Patients with sore throat, respiratory tract infection, and hoarse voice 7 days before randomization; (4) Long-term (within 3 months) use of non-steroidal anti-inflammatory drugs; (5) Patients with previous bronchial asthma; (6) Mallampati score > 2; (7) A history of myocardial infarction and unstable angina pectoris within 6 weeks before the screening period; (8) Bradycardia (heart rate = 160mmHg and/or diastolic blood pressure >= 100mmHg during the screening period); (10) Patients with mental system diseases (such as schizophrenia, depression, etc.) and cognitive dysfunction; patients with a history of epilepsy; past history of psychotropic and narcotic drug abuse; (11) Drug abuse within 2 years before randomization History, history of drug abuse and alcohol abuse, alcoholism means drinking more than 2 units of alcohol per day on average (1 unit=360ml beer or 45ml liquor with 40% alcohol content or 150ml wine); (12) Abnormal blood clotting function (PT The prolongation is greater than the upper limit of normal for 3 seconds, the APTT prolongation is greater than the upper limit of normal for 10 seconds); (13) Abnormal liver function, ALT and or AST> 2 times the upper limit of normal; total bilirubin > 1.5 times the upper limit of normal; (14) Abnormal renal function, blood creatinine (Cr) > 1.5 times the upper limit of normal value; (15) Allergy to tetracaine components or components; (16) Pregnant or lactating women; (17) Participated in clinical trials of other drugs and/or devices within 3 months before the screening period; (18) Patients judged by the investigator to be unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a sore throat score > 2 at least once at 1h, 6h, and 24h after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1min and 3min after tracheal intubation, the change of heart rate per minute compared with baseline;1min and 3min after tracheal extubation, the change of heart rate per minute compared with baseline;Sore throat score of patients at 1h, 6h, 1-7 days after operation;Hoarseness score of patients at 1h, 6h, and 1-7 days after operation;Evaluation of subjects’ satisfaction with the surgical procedure;Subject's hospital stay; | — |
Countries
China
Contacts
Public ContactLi cai
Southern Hospital of Southern Medical University
Outcome results
None listed