Sphenopalatine Block Vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

Not Applicable

Not yet recruiting

• Conditions: Sphenopalatine Ganglion Nerve Block; Transnasal Endoscopic Pitutary Surgery
• Interventions: Other: General Anesthesia (control group); Procedure: Sphenopalatine Ganglion Block; Drug: Dexmedetomidine

• Registration Number: NCT06639659
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-26
• Study Start: 2024-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C (control group) (n=23) patients will be operated under general anesthesia.	General Anesthesia (control group)	-
Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block	Sphenopalatine Ganglion Block	-
Group DEX (n=23) patients will receive dexmedetomidine drug.	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain using VAS scale.	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.
Surgical field using Average Category Scale (ACS).	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.

Trial Locations

Locations (1)

Zagazig Univesity Hospital; 🇪🇬 Zagazig, Egypt