Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery

Zagazig University

Status: Active, not recruiting

Conditions: Sphenopalatine Ganglion Nerve Block; Transnasal Endoscopic Pitutary Surgery

Treatments: Other: General Anesthesia (control group); Procedure: Sphenopalatine Ganglion Block; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06639659

sphenopalatine block in TEPS

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 estimated patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 3 patient groups, including a placebo group

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

Placebo Comparator group

Treatment:

Other: General Anesthesia (control group)

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

Active Comparator group

Treatment:

Procedure: Sphenopalatine Ganglion Block

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

Active Comparator group

Treatment:

Drug: Dexmedetomidine