We conducted a prospective cohort study on patients who underwent an elective supratentorial craniotomy between 2019 and 2020. This survey was approved by the Ethics Committee of Shahid Beheshti University of Medical Sciences (code:
IR.SBMU.RETECH.REC.1398.074) and followed the Declaration of Helsinki study protocol. All patients who were included in the study were informed about the purpose of the study, and written informed consent was obtained from them. We included all the patients who were candidates for supratentorial craniotomy, aged over 18 to 80 years old, and were able to fully complete the questionnaire. Patients with a history of neuromuscular disorders, abnormal airway examinations, hypoparathyroidism, acromegaly, craniofacial abnormality, or previous airway surgery were excluded. Additionally, patients who experienced perioperative complications, lost more than 15% of intravascular volume, had craniotomies lasting more than four hours, or were transferred to the intensive care unit (ICU) while intubated were also excluded. As part of the study, patients who agreed to participate were given a preoperative visit and were asked to complete the STOP-Bang Questionnaire. Those with a score of less than three were classified as low-risk, while those with a score of three or higher were classified as high-risk. The Mallampati score was completed by a single anesthesiologist (EY) to predict difficulty in intubation based on the relation of the uvula, throat, and soft palate (
22,
23). The EY instructed all patients to open their mouths and extend their tongues as much as possible. Patients were supine while the EY was measuring the Mallampati score. Patients were asked to remain silent during this process. Based on their observations, patients were classified into four categories: Class I, II, III, and IV (
24). We divided patients into two groups: Those labeled as class I and II may have easy intubation, while the other two may experience hard intubation. Supratentorial craniotomy means the exposure of any part of a cerebral hemisphere over the basal line, joining the nasion to the inion (
25). In this study, patients underwent craniotomy for supratentorial tumor. The anesthetic induction process was standardized for all patients in the study. Each patient was administered 0.02 mg/kg of midazolam, 2 mg/kg of propofol, 2 microgr/kg of fentanyl, 1 mg/kg of lidocaine, and 0.5 mg/kg of atracurium. Maintenance was achieved through the infusion of 100 microgr/kg of propofol and fentanyl. Throughout the surgical procedure, we closely monitored the patient's depth of anesthesia using the Bispectral Index (BIS) and maintained the BIS value between 45 and 55. The atracurium dose was repeated every thirty minutes during the surgery. Afterwards, patients were extubated in the operating room (OR) at the end of the surgery. Then, all patients received 100% oxygen via a face mask. They were then transferred to the recovery room where their pulse and oxygen levels were monitored by pulse oximetry. Besides, we monitored the patients’ blood pressure. While hospitalized, we kept track of any airway obstruction that required intervention (such as nasal or oral airway, jaw thrust, and reintubation), hypoxia, respiratory distress, tachypnea, complaints of difficulty in respiration or swallowing, hypotension, myocardial infarction, and new atrial fibrillation. All the patients were followed up until the end of their stay in neurosurgical ICU. Thus, we also recorded the length of stay in the recovery room and neurosurgical ICU. To effectively address potential biases in the study, several measures were implemented. First, patients were selected at random to further minimize the risk of selection bias, ensuring that the sample was representative of the population. Besides, in order to ensure accurate responses, patients were instructed to complete the questionnaire with care. A qualified general practitioner was assigned to explain each question thoroughly, which helped patients understand the intent behind the questions, thereby facilitating the most accurate responses possible. In addition, to enhance the integrity of the data collection process, the individual responsible for gathering the data was kept unaware of the patients' group allocations. This strategy aimed to prevent any unintentional influence on the data collection process. Moreover, the data analyst tasked with interpreting the results was also blinded to the grouping of participants, maintaining the objectivity of the analysis. Throughout the study, both negative and positive outcomes were meticulously recorded and reported, providing a comprehensive overview of the findings. These steps collectively contributed to a robust methodological framework designed to mitigate biases and ensure the reliability of the study results. The purpose of estimating sample size is to select an adequate number of participants to maintain the likelihood of errors at an acceptable level, while also preventing the study from being excessively large. To calculate the sample size, we used the G*Power software. Based on Vasu et al. study (
26), by considering α = 0.05, and β (power) = 0.90, considering continuity correction, the sample size of 136 was calculated. To increase the precision, we increased the calculated sample size by 50%. The final sample size was 200. To effectively minimize the impact of confounding variables in our study, we implemented a blinding process for both the data analyst and the data collector. This means that neither individual had any knowledge of the participants' group assignments, preventing any potential bias in data interpretation or collection. Furthermore, we made a deliberate decision to limit the number of participants in the study to ensure a more manageable and controlled environment. This approach allowed us to focus on collecting high-quality data, which is critical for drawing reliable conclusions. In addition to these measures, we applied robust statistical methods throughout our analysis. These methods are designed specifically to account for and mitigate the influence of confounding variables, enhancing the validity of our results and allowing for more accurate interpretations of the data collected. The statistical analysis was conducted using SPSS version 20. A descriptive analysis of the data was performed. Qualitative variables were reported as frequencies and percentages, while quantitative variables were displayed as means and standard deviations. We performed Shapiro-Wilk test to assess the normal distribution. If the data were normally distributed, we performed an independent
t-test to compare the difference of variables between the two groups. Otherwise, Mann-Whitney U test was performed. To evaluate the accuracy of forecasting surgery complications, we used the ROC curve. A P-value less than 0.05 was considered statistically significant.