Clinical trial NCT06639659: Sphenopalatine Block Vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery
Official title: Bilateral Supra-Zygomatic Sphenopalatine Ganglion Block Versus Dexmedetomidine for Relief of Postoperative Pain and Surgical Field Improvement in Trans-nasal Endoscopic Pituitary Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sphenopalatine Ganglion Nerve Block
Transnasal Endoscopic Pitutary Surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-10-15
Enrollment: 69
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Improving pain and surgical field by using sphenopalatine ganglion block and dexmedetomidine in trans-nasal endoscopic pituitary surgery.

Detailed description: Pituitary neoplasm is one of the most common sellar pathology. Trans-nasal endoscopic pituitary surgery (TEPS) evolved rapidly, almost replacing the craniotomy approach. TEPS, a surgical instrument, is primarily executed through a minimally invasive approach through the nostril to access a pituitary tumor.

That is why the anesthetic plan must ensure the best possible surgical field visualization and the most adequate analgesia.

Multimodal anesthesia including regional and general anesthesia are obtained to optimize surgical field by decreasing bleeding, reduce pain, promote rapid recovery and potential economic gains for the hospital.

The sphenopalatine ganglion block (SPGB) is considered one of the regional anesthetic techniques that is safe and easy anesthetic procedure used to control bleeding and for postoperative analgesia.

Dexmedetomidine (DEX) has become popular for induced hypotension. It is an α2-adrenoceptor agonist with a sympatholytic and analgesic effect. It provides a unique conscious sedation without respiratory depression. It is used effectively in optimizing surgical field through its hemodynamic stability effect.

Eligibility criteria: Inclusion Criteria:

* Age: between 21-64 years old.
* sex: males and females.
* Body mass index: 35 kg/m2.
* ASA Physical status: grade Ⅰ-Ⅱ.

Exclusion Criteria:

* patients receiving beta blockers, anti-coagulants and antihypertensive medications also patients receiving clonidine or benzodiazepines, neuroleptics or antidepressants two weeks prior to the study.
* Any contraindication for regional anesthesia e.g. coagulopathy, infection at site of block and hypersensitivity to any drug used in this study.
* Patients who are known to be drug addict.

Primary outcomes:
measure: Postoperative pain using VAS scale.
timeFrame: 24hours
measure: Surgical field using Average Category Scale (ACS).
timeFrame: 5hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig Univesity Hospital
Study officials:
References:
citation: Anthony Cometa M, Zasimovich Y, Smith CR. Percutaneous sphenopalatine ganglion block: an alternative to the transnasal approach. Int J Obstet Anesth. 2021 Feb;45:163-164. doi: 10.1016/j.ijoa.2020.10.002. Epub 2020 Oct 17. No abstract available.
citation: Mantovani G, Sgarbanti L, Indaimo A, Cavallo MA, De Bonis P, Flacco ME, Scerrati A. Effects of a sphenopalatine ganglion block on postcraniotomy pain management: a randomized, double-blind, clinical trial. Neurosurg Focus. 2023 Dec;55(6):E13. doi: 10.3171/2023.9.FOCUS23549.
citation: Hutton M, Brull R, Macfarlane AJR. Regional anaesthesia and outcomes. BJA Educ. 2018 Feb;18(2):52-56. doi: 10.1016/j.bjae.2017.10.002. Epub 2017 Nov 27. No abstract available.