Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First People's Hospital of Lianyungang

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;

ASA grade I ~ III;

Scheduled elective surgery under general anesthesia with tracheal intubation.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tegilerdine

    Drug

    Inject Tegilerdine in the induction of general anesthesia

  • Sufentanil

    Drug

    Inject Sufentanil in the induction of general anesthesia

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Tegilerdine groupExperimental treatment 1 intervention
Group B: Sufentanil groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of choking cough response

Two minutes after administration of the study drugs (Tegilerdine/Sufentanil), any clear coughing action is considered an 'occurrence'.

Time frame
2 minutes after administration

Secondary outcomes

1

Grading of choking and coughing response

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

Time frame
2 minutes after administration
2

Blood pressure

Blood pressure before and after administration, and before and after intubation

Time frame
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)
3

Heart rate

heart rate before and after administration, and before and after intubation

Time frame
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)
4

Adverse reaction

such as respiratory depression, vomiting, nausea, itching, etc.)

Time frame
2 minutes after administration

Other outcomes

Sponsors and contacts

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