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Active, not recruitingNCT06639659Updated Jan 2, 2026

Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

An interventional study of Sphenopalatine Ganglion Block and Dexmedetomidine in Sphenopalatine Ganglion Nerve Block and Transnasal Endoscopic Pitutary Surgery, sponsored by Zagazig University. Active, not recruiting at 1 site in Egypt. Open to participants aged 21 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Zagazig University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
21 Years to 64 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Sphenopalatine Ganglion Nerve Block
  • Transnasal Endoscopic Pitutary Surgery
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In context

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
69 participants (estimated)

Study arms

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

    Other: General Anesthesia (control group)

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

    Procedure: Sphenopalatine Ganglion Block

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

    Drug: Dexmedetomidine

Interventions

  • ProcedureSphenopalatine Ganglion Block

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

  • DrugDexmedetomidine

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

  • OtherGeneral Anesthesia (control group)

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

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What researchers measure

Primary outcomes

  1. Postoperative pain using VAS scale.

    Pain will be assessed based on VAS scale from (1-10), as 1 is the least pain and 10 is the maximal pain possible at 2, 4, 6, 12 and 24h after surgery.

    Time frame: 24hours

  2. Surgical field using Average Category Scale (ACS).

    Done by asking the surgeon about amount of bleeding on a scale of (0-5) as 0= no bleeding and 5= sever bleeding, every 15 min interval till the end of surgery.

    Time frame: 5hours

07

Study locations

1 site
  • Zagazig Univesity Hospital
    Zagazig, Egypt
08

References and documents

Publications

  • 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. PubMed 33199256 ↗
  • 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. PubMed 38262005 ↗
  • 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. PubMed 33456810 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06639659
Lead sponsor
Zagazig University
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Oct 1, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jan 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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