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Clinical Trials/NCT05301634
NCT05301634
Completed
Phase 3

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

Cairo University1 site in 1 country60 target enrollmentApril 2, 2022
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ConditionsIntraoperative Hypertension

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Intraoperative Hypertension
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Mean arterial blood pressure
Status
Completed
Last Updated
4 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2, 2022
End Date
December 15, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Mean arterial blood pressure

Time Frame: at the time of mucosal dissection

Secondary Outcomes

  • Intraoperative need for nitroglycerine(the entire duration of surgery)
  • Postoperative need of pethidine(24 hours postoprative)
  • Intraoperative need for magnesium sulphate(the entire duration of surgery)
  • Intraoperative need for fentanyl(the entire duration of surgery)
  • Postoperative pain assessed by Numeric pain score(24 hours postoprative)

Study Sites (1)

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