NCT06639659

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

September 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 2, 2026

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 26, 2024

Last Update Submit

December 31, 2025

Conditions

Transnasal Endoscopic Pitutary SurgerySphenopalatine Ganglion Nerve Block

Outcome Measures

Primary Outcomes (2)

  • 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.

    24hours

  • 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.

    5hours

Study Arms (3)

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

PLACEBO COMPARATOR
Other: General Anesthesia (control group)

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

ACTIVE COMPARATOR
Procedure: Sphenopalatine Ganglion Block

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

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Interventions

Sphenopalatine Ganglion BlockPROCEDURE

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

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

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

Group DEX (n=23) patients will receive dexmedetomidine drug.
General Anesthesia (control group)OTHER

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

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

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig Univesity Hospital

Zagazig, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 33199256RESULT

  • 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.

    PMID: 38262005RESULT

  • 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.

    PMID: 33456810RESULT

MeSH Terms

Interventions

Sphenopalatine Ganglion BlockDexmedetomidineAnesthesia, GeneralControl Groups

Intervention Hierarchy (Ancestors)

Autonomic Nerve BlockNerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 15, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 2, 2026

Record last verified: 2025-09

Locations

EG(1)