Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

N/AActive Not RecruitingNCT06639659

Zagazig University69 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

Conditions

Sphenopalatine Ganglion Nerve Block Transnasal Endoscopic Pitutary Surgery

Interventions

Sphenopalatine Ganglion BlockPROCEDURE

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

DexmedetomidineDRUG

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

General Anesthesia (control group)OTHER

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zagazig Univesity Hospital

Zagazig, Egypt

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.