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IRCT20200907048652N2 IRCT 2021-01-02 Shiraz University of Medical Sciences Evaluation of the effect of gabapentin on patients restlessness after rhinoplasty Evaluation of the effect of gabapentin on patients restlessness after rhinoplasty 2019-09-04 anticipated 120 Complete https://irct.ir/trial/53408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were randomized according to a pre-prepared list by Block Randomization method in which each of the numbers from 1 to 120 was placed in one of two groups A or B. The mentioned list along with medicine and placebo was kept in the operating room by a person outside the study and after announcing the desired number by the person doing the plan, the medicine or placebo was given to him according to the list so that the person doing it was unaware of the patient group, Blinding description: After explaining the conditions and stages of the study, written consent was obtained from all patients to enter the study and patients were not aware of receiving medication and placebo. Also, the list of patients with medication and placebo was kept in the operating room by a person outside the study, and after announcing the desired number by the person performing the plan, the drug or placebo was given to him according to the list, so that the person performing it was unaware of the patient group. 3 Rhinoplasty surgery. Intervention 1: Intervention group: Patients were given two 300 mg (600 mg) capsules of gabapentin half an hour before surgery, with a small amount of water. Intervention 2: Control group: In the control group, two capsules of the same color, shape and size containing placebo were given half an hour before the operation, which was consumed with a small amount of water. Yes - There is a plan to make this available What will be shared: The results of the study will be published as an article. The study protocol and statistical analysis used in the article will be considered. When: The information will be published one year after the end of the study and will be available in the sources. To whom: With the sponsor's permission, the information will be available to academic researchers, physicians, and academic institutions. Conditions: Other researchers can use the results of the study in their review and meta-analysis. Where to obtain: Hamidreza Hosseinpour - Shiraz, Zand St., Shiraz University of Medical Sciences, School of Medicine - Department of Surgery How to obtain: Upon receipt of the application, the scientific officer of the study will respond to the applicant within two weeks, depending on the type of information requested, after coordination with the sponsor. Comments:
public Hamidreza Hosseinpour
Unit 2-nastaran bldg-8th alley
Shiraz Iran (Islamic Republic of) 7186611555 +98 71 3631 1594 hp_hamid@ymail.com Shiraz University of Medical Sciences scientific Hamidreza Hosseinpour
Unit 2-nastaran bldg-8th alley
Shiraz Iran (Islamic Republic of) 7186611555 +98 71 3631 1594 hp_hamid@ymail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All female candidates for rhinoplasty with ASA class I or II that were referred to Amir Al-Momenin Hospital, Namazi or Kosar Hospital in Shiraz. 17 years 55 years Female Patients with a diagnosis of dementia, patients with severe preoperative anxiety (yes or no is asked by the physician), patients with impaired kidney function, patients with a long history (more than 1 month) of anti-anxiety drugs, antidepressants, Neuroleptics, benzodiazepines, diabetics and patients with a history of chronic pain were not included in the study. Prevention Prevention Intervention group: Patients were given two 300 mg (600 mg) capsules of gabapentin half an hour before surgery, with a small amount of water. Control group: In the control group, two capsules of the same color, shape and size containing placebo were given half an hour before the operation, which was consumed with a small amount of water. Post operative restlessness. Timepoint: Immediately after the operation and then at the time of recovery. Method of measurement: Based on Riker sedation - agitated scale to measure arterial oxygen saturation, arterial blood pressure, heart rate and exhaled CO2. Pain level. Timepoint: at the time of recovery. Method of measurement: Based on the Numeric Rating Scale. Shiraz University of Medical Sciences Approved 2019-09-14 Ethics committee of Shiraz University of Medical Sciences Zand street shiraz Fars Iran (Islamic Republic of)