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Completed

NCT Number: NCT03364283

Sitting Versus Horizontal Position on Craniotomies

The main objectives of this study are comparison of the incidence of intraoperative air embolism and the extent of blood loss in patients undergoing posterior cranial fossa (PCF) and pineal region (PR) surgeries in sitting and horizontal position. Additionally, the overall treatment outcome, neurological functional outcome, degree of tumor removal, clinical course in the postoperative period, and the patient satisfaction will be compared between the groups.

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Key information

About this study

This was a prospective observational study to assess the effects of patient positioning during craniotomies on surgical outcomes. Patients were distributed into 2 major groups based on the surgical position: sitting and horizontal. Each group was further divided into subgroups based on the type and location of the lesion. To achieve the study goals, comparison of the 2 approaches in equivalent patient groups was performed, including comparable demographics, diagnoses, topographic location of the lesions, anesthetic approaches, and surgical experience.

The operating surgeons decided patient positioning based on clinical judgment. Type of anesthesia was defined by the anesthesiologist in charge of the patient however, it was maximally standardized for both sites. All the surgeries were performed by neurosurgeons with sufficient experience of sitting craniotomies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 - 75 years old undergoing open posterior cranial fossa and pineal region surgery and diagnosed with space-occupying or vascular lesions willing consent to participate in the study.

Exclusion criteria

  • Significant cardio-vascular comorbid conditions (cardiac insufficiency, recent infarction, advanced arterial hypertension)
  • Advanced chronic respiratory comorbid conditions
  • Uncorrected hypovolemia, anemia, hypoalbuminemia
  • De-compensated acid base and electrolyte disorders
  • Anticoagulated patients and patients with coagulation disorders, deep venous thrombosis (history of deep vein thrombosis or clinically established)
  • Preoperative evidence of spinal or peripheral nerve dysfunction that may interfere with patient positioning.
  • Cervical myelopathy
  • Cervical spine disorders (atlanto-occipital arthritis, previous fractures etc.)

Treatment and study plan

Surgical position

Procedure

Primary outcomes

  1. Incidence of intraoperative air embolism

    Time frame: Time of surgery (From surgical wound incision time until wound closure)

    Measured intraoperatively with transesophageal echocardiogram and/or PETCO2 levels

Secondary outcomes

  1. Degree of tumor removal

    Time frame: End of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgery

    Indicated by surgeon description and/or postoperative imaging

  2. Neurological function

    Time frame: End of surgery (closure) - Discharge from the hospital or up to 3 months after end of surgery, whichever came first.

    Compared sensory-motor function, cranial nerve function and Glasgow scale before and after surgery.

  3. Patient satisfaction

    Time frame: End of surgery (closure) - 3 months after surgery

    Collected on phone script during follow-up phone call

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Burdenko Neurosurgery Institute

Registry information

Official study title

The Effects of Sitting Position on the Outcome During Surgery on Posterior Cranial Fossa and Pineal Region

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2017
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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