Evaluation of the effect of gabapentin on patients restlessness after rhinoplasty

In this study, the effect of prescribing a single dose of 600 mg of gabapentin before surgery on the rate of restlessness at the time of withdrawal from anesthesia in patients undergoing rhinoplasty is investigated.

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2-3 on 120 patients was designed. Block Randomization method was used for randomization

This study was performed in Amir Al-Momenin, Namazi, and Kosar hospitals in Shiraz. This trial was performed on 120 patients who were candidates for rhinoplasty in the intervention and control groups. Patients were treated with gabapentin half an hour before surgery according to the defined protocol, and the intervention group received a placebo instead of a drug.

Female candidates for rhinoplasty with ASA class I or II were referred to Amir Al-Momenin Hospital, Namazi or Kosar Hospital in Shiraz. Patients with a diagnosis of dementia, patients with severe preoperative anxiety (yes or no is asked by a doctor), patients with impaired kidney function, patients with a long history (more than 1 month) of anti-anxiety, anti-depressant, neuroleptic drugs, Benzodiazepines, diabetic patients and patients with a history of chronic pain were not included in the study.

Patients in the intervention group were given two 300 mg (600 mg) gabapentin capsules half an hour before the start of rhinoplasty, which was consumed with a small amount of water. In the control group, two capsules of the same color, shape, and size containing placebo were given half an hour before the start of surgery.

Immediately after the operation and during recovery, the patient's restlessness, arterial O2 saturation, arterial blood pressure, heart rate, and expiratory CO2, nausea, and pain were recorded.

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.

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.

The results of the study will be published as an article. The study protocol and statistical analysis used in the article will be considered.

The information will be published one year after the end of the study and will be available in the sources.

With the sponsor's permission, the information will be available to academic researchers, physicians, and academic institutions.

Other researchers can use the results of the study in their review and meta-analysis.

Hamidreza Hosseinpour - Shiraz, Zand St., Shiraz University of Medical Sciences, School of Medicine - Department of Surgery

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.