Lidocaine in ERAS for FESS
Lidocaine Infusion in Functional Endoscopic Sinus Surgery
1 other identifier
interventional
43
1 country
2
Brief Summary
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2017
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedStudy Start
First participant enrolled
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 28, 2022
April 1, 2022
4.9 years
February 6, 2017
April 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intraoperative bleeding
Will be calculated from the fluid volume of the suction canister. The volume of irrigating fluid will subtracted from the total volume of fluid contained in the suction bottle. Additionally, a fully soaked cotton strip will be assumed to contain 5 ml of blood and a partially soaked one to contain 2-3 ml of blood
Intraoperative assessment till end of operation
Secondary Outcomes (4)
Quality of surgical field
intraoperative assessment
Surgeon satisfaction
At the end of surgery
Mean arterial pressure
intraoperative assessment
Heart rate
intraoperative assessment
Study Arms (2)
Lidocaine
ACTIVE COMPARATORIV Lidocaine infusion
Control
PLACEBO COMPARATORIV normal saline infusion
Interventions
Eligibility Criteria
You may qualify if:
- Patients, 20-50 yr ASA class I and II
- Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.
You may not qualify if:
- Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index \> 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of Medicine Assuit University
Asyut, Assuit, 71111, Egypt
Seham Mohamed Moeen Ibrahim
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seham M Moeen, MD
Assiut University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 8, 2017
Study Start
February 9, 2017
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share