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

Cerebral Tumor Clinical Trial

Official title:

Effect of Sphenopalatine Ganglion Block on Intracranial Pressure and Cerebral Venous Outflow Oxygenation During Craniotomy for Supratentorial Brain Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434651
• Other study ID #: 6180
• Status: Completed
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: August 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 15, 2021
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Tumor

Intervention

Procedure:
• SPGB
Sphenopalatine Ganglion Block using 2% lidocaine in block group. Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge a syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril SPGB using normal saline is performed in the control group

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Feldman Z, Robertson CS. Monitoring of cerebral hemodynamics with jugular bulb catheters. Crit Care Clin. 1997 Jan;13(1):51-77. Review. — View Citation

Kaye AD, 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):1127-32, table of contents. Erratum in: Anesth Analg. 2016 Mar;122(3):922. Kaye, Alan [corrected to Kaye, Alan David]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial Pressure	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.	Every 20 minutes until time of initial craniotomy, then again after the dura was sutured.
Secondary	Jugular venous bulb oxygen saturation and cerebral arteriovenous oxygen content difference.	Jugular venous bulb oxygen saturation will be measured then AVDO2 will be calculated.	Every 20 minutes throughout the operation period.