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Trial Title:
Sphenopalatine Block Vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery
NCT ID:
NCT06639659
Condition:
Sphenopalatine Ganglion Nerve Block
Transnasal Endoscopic Pitutary Surgery
Conditions: Official terms:
Ganglion Cysts
Synovial Cyst
Dexmedetomidine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Sphenopalatine Ganglion Block
Description:
patients will receive ultrasound guided bilateral supra-zygomatic sphenopalatine ganglion
block.
Arm group label:
Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block
Intervention type:
Drug
Intervention name:
Dexmedetomidine
Description:
patients will receive 1 µg/kg dexmedetomidine within 10 minutes, followed by maintenance
dose throughout the surgery.
Arm group label:
Group DEX (n=23) patients will receive dexmedetomidine drug.
Intervention type:
Other
Intervention name:
General Anesthesia (control group)
Description:
patients will be operated under general anesthesia including routine protocol for these
cases
Arm group label:
Group C (control group) (n=23) patients will be operated under general anesthesia.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
21 Years
Maximum age:
64 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zagazig Univesity Hospital
Address:
City:
Zagazig
Country:
Egypt
Start date:
October 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Zagazig University
Agency class:
Other
Source:
Zagazig University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06639659
