A comparative study of the effect of two doses of sufentanil continuous infusion on changes in heart rate and blood pressure after laryngoscopy and tracheal intubation.

Determining and comparing the effect of two-dose sufentanil continuous infusion on changes in heart rate and blood pressure after laryngoscopy and tracheal intubation.

A randomized, triple-blinding clinical trial, with parallel groups, Phase 3 on 90 patients

In this three-blind randomized clinical trial study, 90 eligible patients referred to Al-Zahra Hospital in Isfahan will be included in the study and will be randomly divided into 3 groups. During induction of anesthesia, sufentanil with a dose of 0.1 μg/kg, 0.2 μg/kg, and normal saline will be prescribed in three groups, respectively. The intervention will be performed in such a way that the patient, the researcher, and the statistical analyst will have no knowledge of the type of intervention. Then the hemodynamic parameters of patients will be evaluated and compared among the three groups.

The criteria for inclusion in the study include the age group of 18 to 65 years, having an American Association of Anesthesiologists (ASA) I, and requiring tracheal intubation for general anesthesia. Exclusion criteria include having Comorbidity(such as heart failure, respiratory, liver, kidney failure, and airway malformations), and addiction.

Intervention group 1: In this group, anesthesia is induced within 60 seconds using sodium thiopental 5 mg/kg, lidocaine 1.5 mg/kg, atracurium 0.6 mg/kg, and sufentanil with a dose of 0.1 μg/kg. The second intervention group: in this group, in addition to the drugs of the first group, sufentanil is infused at a dose of 0.2 μg/kg within 60 seconds. Control group: in this group, in addition to the drugs of the first group, normal saline is prescribed instead of sufentanil.

Systolic blood pressure, diastolic blood pressure, heart rate, oxygen saturation(Spo2)

Before starting the study, letter A is written on 30 sheets, letter B is written on 30 sheets, and letter C is written on 30 sheets and each is placed in an envelope. Then, each eligible patient who consented to participate in the study is asked to choose an envelope from among the envelopes. In this way, the patient will be randomly assigned to one of the three groups according to the envelope selected without the interference of the researcher.

In order to achieve the triple-blind study, different doses of sufentanil and placebo will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, and C. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.

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