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IRCT20210415050983N13 IRCT 2026-06-14 Shahid Beheshti University of Medical Sciences Evaluation of Lung-Protective Ventilation on Intraoperative Bleeding During Endoscopic Pituitary Adenoma Surgery Impact of Lung-Protective Ventilation Strategies and on Intraoperative Blood Loss and Surgical Field Quality in Endoscopic Endonasal Transsphenoidal Pituitary Adenoma Surgery: A Randomized Clinical Trial 2026-08-23 anticipated 140 Recruiting https://irct.ir/trial/90210 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to two groups using a 1:1 quadratic block randomization method. The random sequence will be generated by software and stored in sealed, numbered envelopes, Blinding description: The study will be conducted in a single-blind manner, so that the patient and surgeon will not be aware of the assigned ventilation mode, but the anesthesiologist will be aware of the study group due to the need to adjust the ventilation device (anesthesia machine). 2 Skull base tumors are candidates for surgery.. Intervention 1: Intervention group:Patients will be placed on lung protective ventilation with a tidal volume of 6 cc/kg ideal body weight during general anesthesia. Intervention 2: Control group: Patients will be ventilated conventionally with a tidal volume of 8 cc/kg ideal body weight during general anesthesia. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Restriction of some magazines to publish
public sogol asgari
South Kargar St. Kamali St. Special Loghman Hakim Hospital
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5102 5000 drasgari98429@gmail.com Shahid Beheshti University of Medical Sciences scientific hasanali ahmadi
South Kargar St. Kamali St. Special Loghman Hakim Hospital
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5102 5000 drahmadi129357@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age >18 ASA I–II tumor size : microadenoma Patient satisfaction 18 years 80 years Both Patient with heart failure (EF<40%) sever pulmonary disease need to abnormal ventilation uncorrected coagulation disorders or use of blood-thinning medication that have not been discontinued pregnancy Changing the surgical plan or converting to a non-endoscopic procedure Severe hemodynamic instability during surgery requires a change in anesthesia and ventilation protocol. Previous history of pituitary surgery Non-adenomatous tumors of the sellar and parasellar regions D33.2 Benign neoplasm of brain, unspecified Treatment - Other Treatment - Other Intervention group:Patients will be placed on lung protective ventilation with a tidal volume of 6 cc/kg ideal body weight during general anesthesia. Control group: Patients will be ventilated conventionally with a tidal volume of 8 cc/kg ideal body weight during general anesthesia. Intraoperative bleeding. Timepoint: Recorded periodically (every 15–30 minutes) and at the end of surgery. Method of measurement: Suction volume (ml) minus recorded irrigation volume.Sponges/gauzes: pre-operative dry weight (g) and post-use weight; weight difference converted to ml. Hemodynamic parameters (blood pressure and heart rate). Timepoint: Every 5–15 minutes. Method of measurement: Standard monitoring. Surgical field of view quality. Timepoint: End of surgery. Method of measurement: Fromme-Boezaart scale. Duration of surgery. Timepoint: End of surgery. Method of measurement: Record in the file. Need for blood transfusion. Timepoint: During surgery. Method of measurement: Record in the file. Shahid Beheshti University of Medical Sciences Approved 2026-05-17 Loghman Clinical Research Development Unit South Kargar St. - Kamali St. - Special St. تهران Tehran Iran (Islamic Republic of)