Comparing the effects of clonidine, morphine and promethazine as pre-medication on intraoperative bleeding and hemodynamic stability of patients during septorhinoplasty surgeries

to compare the effects of clonidine, promethazine, and morphine as premedication on intraoperative bleeding and hemodynamic stability of patients during septorhinoplasty surgeries

The population of the study include all the patients who are candidate for septorhinoplasty in Birjand in 2017. A total of 60 patients who are candidate for septorhinoplasty will be selected by convenience sampling method and assigned into three groups of clonidine, promethazine and morphine (20 patients per group) using table of random numbers. The study will be conducted in two centers in the second phase of clinical trials.

The study will be performed in Valieasr and Razi hospitals of Birjand; moreover, the study is triple-blinded.

Major inclusion criteria consist of age from 18 to 60 years; lack of bleeding disorders such as hemophilia, thalassemia and leukemia; and lack of treatment with anti-coagulant drugs. Major exclusion criteria comprise of having systolic blood pressure above 160 mmHg and diastolic blood pressure above 90 mmHg; and unwillingness to collaborate in the study.

Patients in the clonidine and promethazine groups will receive 300 milligrams of clonidine tablet and 25 milligrams of promethazine tablet, respectively, one hour before surgery. Patients in the morphine group will also receive 0.1 milligrams/killogram body weight of morphine intramuscularly an hour before surgery. For induction of anesthesia, 100 micrograms of fentanyl and 1.5-2 milligrams/killogram body weight propofol and 0.5 milligram/kilogram atracurium will be injected. After reaching the sufficient depth of anesthesia, intubation will be performed using an appropriate tracheal tube. The anesthetic preservative will be propofol infusion at a dose of 100 micrograms/kilogram body weight per minute. To create controlled hypotension, infusion of remifentanil with a dose of 0.1 microgram/kilogram body weight per minute will be used.

Systolic and diastolic blood pressures, mean arterial pressure, pulse, and saturation of red blood cells will be measured by the monitoring device (provided by Saadat Company) before induction of anesthesia, after intubation of the patient, and every 30 minutes after the onset of operation.

Allocation is via table of random numbers.

Firstly, the participants are blind to the pre-medication they are to receive. Although they are explained about the study design and procedure, they are not informed of the type of medication they will receive, especially because the medications are already established as standard drugs. Moreover, on-site evaluators and statistical analysts are not aware of the study groups.

The majority of participants agreed to participate if the confidentiality of data would be guaranteed, given the type of surgery they would undergo.

Informed Consent for Participation

Unlimited

Any researcher

To complete and to express viewpoints

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