Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

December 31, 2025 updated by: Zagazig University

Bilateral Supra-Zygomatic Sphenopalatine Ganglion Block Versus Dexmedetomidine for Relief of Postoperative Pain and Surgical Field Improvement in Trans-nasal Endoscopic Pituitary Surgery

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig Univesity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group C (control group) (n=23) patients will be operated under general anesthesia.
Other: General Anesthesia (control group)
patients will be operated under general anesthesia including routine protocol for these cases
Active Comparator: Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block
Procedure: Sphenopalatine Ganglion Block
patients will receive ultrasound guided bilateral supra-zygomatic sphenopalatine ganglion block.
Active Comparator: Group DEX (n=23) patients will receive dexmedetomidine drug.
Drug: Dexmedetomidine
patients will receive 1 µg/kg dexmedetomidine within 10 minutes, followed by maintenance dose throughout the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain using VAS scale.
Time Frame: 24hours
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).
Time Frame: 5hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sphenopalatine block in TEPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sphenopalatine Ganglion Nerve Block

Clinical Trials on General Anesthesia (control group)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe