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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05301634
Other study ID # MS-532-2021
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 2, 2022
Est. completion date October 2022

Study information

Verified date May 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
infraorbital block
the patients will receive bilateral infraorbital block
topical intranasal bupivacaine
the patients will receive topical intranasal application of bupivacaine

Locations

Country Name City State
Egypt Kasr Alaini hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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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