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

NCT04434651 | Completed DMC

• 1 other identifier: 6180
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Tumor

Keywords

SPGB; ICP; CBF; AVDO2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Jugular venous bulb oxygen saturation and cerebral arteriovenous oxygen content difference.

  Every 20 minutes throughout the operation period.

Study Arms (2)

Block group (A)

EXPERIMENTAL

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.

Procedure: SPGB

control sham group (B)

SHAM COMPARATOR

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

Procedure: SPGB

Interventions

SPGB PROCEDURE

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

Also known as: Sphenopalatine ganglion block

Block group (A); control sham group (B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine, Zagazig University

Zagazig, 44519, Egypt

Location

Related Publications (2)

• 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.

  PMID: 15041612 BACKGROUND

• 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.

  PMID: 9012576 BACKGROUND

MeSH Terms

Interventions

Sphenopalatine Ganglion Block

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Naglaa Abdelhaleem, MD

  Faculty of Medicine, Zagazig University, Zagazig, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: June 17, 2020
• Study Start: June 17, 2020
• Primary Completion: December 29, 2020
• Study Completion: February 15, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available 3 months after publication of study
• Access Criteria: By contacting the principal investigator

Locations

EG (1)