Intraoperative Hypertension Clinical Trial
Official title:
Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study
Verified date | May 2022 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | October 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - ASA I, II or III - patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia Exclusion Criteria: - Patient's refusal - Allergy to local anesthetics. - Preoperative cerebrospinal fluid leak. - Preoperative cardiac arrythmias. - Seizure disorders. - Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alaini hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean arterial blood pressure | at the time of mucosal dissection | ||
Secondary | Intraoperative need for magnesium sulphate | Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline | the entire duration of surgery | |
Secondary | Intraoperative need for fentanyl | Intraoperative need for iv fentanyl blouses 0.5 µg/kg (maximum total dose 5 µg/kg for the entire procedure) if no response to magnesium sulphate | the entire duration of surgery | |
Secondary | Intraoperative need for nitroglycerine | Intraoperative need for iv nitroglycerine infusion (5 - 100 mic/min iv) if no response to magnesium sulphate and fentanyl | the entire duration of surgery | |
Secondary | Postoperative need of pethidine | Postoperative need of pethidine boluses 25 mg with max.100 mg | 24 hours postoprative | |
Secondary | Postoperative pain assessed by Numeric pain score | Pain score will be assessed postoperatively (using the verbal Numeric Rating Scale [NRS] 0-100; 0 = Non ,100 = Worst imaginable pain) | 24 hours postoprative |
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