Comparison of the effect of infusion of two doses of remifentanil on bleeding rate, intraoperative hemodynamic changes, and complications after rhinoplasty after general anesthesia

Determining and comparing the effect of two doses of remifentanil infusion on bleeding volume, hemodynamic changes during surgery, and complications after rhinoplasty surgery.

A randomized, triple-blinding clinical trial, with parallel groups, Phase 2-3 on 60 patients

In this three-blind randomized clinical trial study, 60 eligible patients referred to Al-Zahra Hospital in Isfahan will be included in the study and will be randomly divided into two groups. After general anesthesia, remifentanil infusion takes place at a rate of 50-100 mcg/kg and 100-150 mcg/kg will be prescribed in two 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 bleeding rate, hemodynamic parameters, and complications after surgery will be evaluated and compared between the two groups.

The criteria for entering the study include the age group of 18 to 50 years, a candidate for rhinoplasty, with ASA class I or II (American Society of Anesthesiologists), and consent to participate in the study. Exclusion criteria include a history of a previous rhinoplasty, sensitivity to remifentanil, opioid abuse, bleeding disorder, and use of contraceptive methods.

The first intervention group: In this group, after general anesthesia, remifentanil infusion is done at a rate of 50-100 mcg/kg. The second intervention group: in this group, after general anesthesia, remifentanil infusion takes place at a rate of 100-150 mcg/kg.

Systolic blood pressure, diastolic blood pressure, heart rate, oxygen saturation(Spo2); Bleeding volume; Bradycardia; hypertension; nausea; Vomiting

Before starting the study, letter A is written on 30 sheets, letter B 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 two groups according to the envelope selected without the interference of the researcher.

In order to achieve the triple-blind study, different doses of remifentanil will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A and B. 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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