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Sitting Versus Horizontal Position on Craniotomies

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03364283
Enrollment
109
Registered
2017-12-06
Start date
2015-10-31
Completion date
2019-04-23
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Craniotomy

Keywords

Posterior fossa, Pineal region

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESurgical position

Sponsors

Burdenko Neurosurgery Institute
CollaboratorOTHER
Ohio State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of intraoperative air embolismTime of surgery (From surgical wound incision time until wound closure)Measured intraoperatively with transesophageal echocardiogram and/or PETCO2 levels

Secondary

MeasureTime frameDescription
Degree of tumor removalEnd of surgery (closure) - Postoperative evaluation by surgeon and/or postoperative imaging performed up to 48 hours after end of surgeryIndicated by surgeon description and/or postoperative imaging
Neurological functionEnd 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.
Patient satisfactionEnd of surgery (closure) - 3 months after surgeryCollected on phone script during follow-up phone call

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026