Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

NCT ID: NCT06639659

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sphenopalatine Ganglion Nerve Block Transnasal Endoscopic Pitutary Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group C (control group) (n=23) patients will be operated under general anesthesia.

Group Type PLACEBO_COMPARATOR

General Anesthesia (control group)

Intervention Type OTHER

patients will be operated under general anesthesia including routine protocol for these cases

Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block

Group Type ACTIVE_COMPARATOR

Sphenopalatine Ganglion Block

Intervention Type PROCEDURE

patients will receive ultrasound guided bilateral supra-zygomatic sphenopalatine ganglion block.

Group DEX (n=23) patients will receive dexmedetomidine drug.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

patients will receive 1 µg/kg dexmedetomidine within 10 minutes, followed by maintenance dose throughout the surgery.

Interventions

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Sphenopalatine Ganglion Block

patients will receive ultrasound guided bilateral supra-zygomatic sphenopalatine ganglion block.

Intervention Type PROCEDURE

Dexmedetomidine

patients will receive 1 µg/kg dexmedetomidine within 10 minutes, followed by maintenance dose throughout the surgery.

Intervention Type DRUG

General Anesthesia (control group)

patients will be operated under general anesthesia including routine protocol for these cases

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zagazig Univesity Hospital

Zagazig, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 33199256 (View on PubMed)

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.

Reference Type RESULT
PMID: 38262005 (View on PubMed)

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.

Reference Type RESULT
PMID: 33456810 (View on PubMed)

Other Identifiers

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sphenopalatine block in TEPS

Identifier Type: -

Identifier Source: org_study_id

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