Comparison of Cough Response Between Tegilidine and Sufentanil as Pre-induction Agents in General Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-04-16

Brief Summary

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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.

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Detailed Description

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Using a computer-generated randomized number table, patients were divided into two groups: the experimental group receiving Tiliglitidine (T group) at 1-7 mg, 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.

Conditions

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General Anesthetic Drug Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tegilidine group

Administer 1-7 mg of Tegilidine before induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction.

Group Type EXPERIMENTAL

Tegilidine

Intervention Type DRUG

Inject Tegilidine in the induction of general anesthesia

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.

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Inject Sufentanil in the induction of general anesthesia

Interventions

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Tegilidine

Inject Tegilidine in the induction of general anesthesia

Intervention Type DRUG

Sufentanil

Inject Sufentanil in the induction of general anesthesia

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes