Clinical trial NCT04434651: Effect of SPGB on ICP and Oxygenation of Cerebral Venous Outflow in Craniotomy for Cerebral Tumors.
Official title: Effect of Sphenopalatine Ganglion Block on Intracranial Pressure and Cerebral Venous Outflow Oxygenation During Craniotomy for Supratentorial Brain Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Tumor
Keywords: SPGB
ICP
CBF
AVDO2
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-06-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be 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 group.

Jugular venous bulb oxygen saturation changes will be recorded every 20 minutes in block and non- block.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracranial Pressure
timeFrame: Every 20 minutes until time of initial craniotomy, then again after the dura was sutured.
Secondary outcomes:
measure: Jugular venous bulb oxygen saturation and cerebral arteriovenous oxygen content difference.
timeFrame: Every 20 minutes throughout the operation period.
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine, Zagazig University
Study officials:
affiliation: Faculty of Medicine, Zagazig University, Zagazig, Egypt.
name: Naglaa Abdelhaleem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaye A, Kucera IJ, Heavner J, Gelb A, Anwar M, Duban M, Arif AS, Craen R, Chang CT, Trillo R, Hoffman M. The comparative effects of desflurane and isoflurane on lumbar cerebrospinal fluid pressure in patients undergoing craniotomy for supratentorial tumors. Anesth Analg. 2004 Apr;98(4):1127-1132. doi: 10.1213/01.ANE.0000105862.78906.3D.
citation: Feldman Z, Robertson CS. Monitoring of cerebral hemodynamics with jugular bulb catheters. Crit Care Clin. 1997 Jan;13(1):51-77. doi: 10.1016/s0749-0704(05)70296-7.