The Affiliated Lianyungang Hospital of Xuzhou Medical University
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The First People's Hospital of Lianyungang
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Incidence of choking cough response
Overview
Brief Summary
In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled, double-blind study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or tegilidine. 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 0.4 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
- •ASA grade I \~ III;
- •Scheduled elective surgery under general anesthesia with tracheal intubation.
Exclusion Criteria
- •Patients with chronic cough (cough lasting \>8 weeks) or asthma;
- •Patients with a history of allergy to the drugs used during the study;
- •Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.
Arms & Interventions
Tegilidine group
Administer 20-50ug/kg of Tegilidine before induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction.
Intervention: Tegilidine (Drug)
Sufentanil group
Administer sufentanil 0.4 µg/kg before the induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction.
Intervention: Sufentanil (Drug)
Outcomes
Primary Outcomes
Incidence of choking cough response
Time Frame: 2 minutes after administration
Two minutes after administration of the study drugs (Tegilidine/Sufentanil), any clear coughing action is considered an 'occurrence'.
Secondary Outcomes
- Grading of choking and coughing response(2 minutes after administration)
- Blood pressure(before injection of Tegilidine 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 injection of Tegilidine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）)
- Adverse reaction(2 minutes after administration)