Effect of SPGB on ICP and Oxygenation of Cerebral Venous Outflow in Craniotomy for Cerebral Tumors.

Not Applicable

Completed

• Conditions: Cerebral Tumor
• Interventions: Procedure: SPGB

• Registration Number: NCT04434651
• Lead Sponsor: Zagazig University

Brief Summary

This study aims to investigate the effect of Sphenopalatine Ganglion Block on ICP and arterio- jugular venous oxygen difference (AJVDO2) and jugular bulb oxygen saturation (SjVO2). Throughout this study, the efficacy of Sphenopalatine Ganglion Block as scalp block in craniotomy operation will be assessed, and the effect of SPGB on cerebral hemostasis during craniotomy will be evaluated by monitoring of both ICP, AJVDO2 and SjVO2.

Detailed Description

This study was performed in the Neurosurgical operating room and included 52 patients allocated into two groups: the treatment group (block group) and the control group (non-block group). 26 patients enrolled in block group and 26 patients in non-block group.

Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both block and non- block groups until craniotomy has been occurred, then at the time of closure of the dura . Arterio- jugular venous oxygen difference and Jugular venous bulb oxygen saturation changes will be recorded every 20 minutes in block and non- block groups throughout time of the surgery till closure of the dura.

Study Timeline

• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-06-15
• Study Start: 2020-06-17
• Study First Posted: 2020-06-17
• Primary Completion: 2020-12-29
• Study Completion: 2021-02-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients who prepared for a neurosurgical intervention for elective supratentorial tumor removal
• ASA 1 and 2
• Age above 18 years and below 65 years
• Fully conscious patients.

Exclusion Criteria

• Patients with cardiovascular and respiratory diseases
• Pregnancy
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control sham group (B)	SPGB	26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line \<10 mm evaluated by CT scan \[computerized tomography\] . SPGB will be performed using normal saline.The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes
Block group (A)	SPGB	26 patients who will be subjected to a neurosurgical intervention for removal of supratentorial brain tumor. Supratentorial brain tumors with shift of the mid-line \<10 mm evaluated by CT scan \[computerized tomography\] . SPGB will be performed using 2 % lidocaine before induction of anesthesia. The anesthesia induced by IV anesthetics and maintained by Isoflurane. ICP, Jugular venous bulb oxygen saturation, and AVDO2 will be assessed every 20 minutes.

Primary Outcome Measures

Name	Time	Method
Intracranial Pressure	Every 20 minutes until time of initial craniotomy, then again after the dura was sutured.	ICP changes checked by a subdural ICP monitor that positioned after the first burr hole at the opposite side of the tumor immediately after induction of anesthesia. ICP monitoring will be conducted every 20 minutes until time of initial craniotomy and at time of closure of the dura.

Secondary Outcome Measures

Name	Time	Method
Jugular venous bulb oxygen saturation and cerebral arteriovenous oxygen content difference.	Every 20 minutes throughout the operation period.	Jugular venous bulb oxygen saturation will be measured then AVDO2 will be calculated.

Trial Locations

Locations (1)

Faculty of Medicine, Zagazig University; 🇪🇬 Zagazig, Egypt