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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03047070
Other study ID # SM22017
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 9, 2017
Est. completion date December 31, 2021

Study information

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

Clinical Trial 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.


Description:

Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and neck field. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes. Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart disease, anemia, preexistent liver or renal damage and endocrine dysfunction (hyperthyroidism, pheochromocytoma and diabetes mellitus). Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming. Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic. Randomized clinical trials, however, have produced mixed results. Several studies have shown reduction in postoperative opioid consumption and pain scores, whereas others have failed to show a benefit.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients, 20-50 yr ASA class I and II - Elective Functional endoscopic sinus surgery (FESS) under general anesthesia. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine
IV Lidocaine infusion
Normal saline
IV normal saline infusion

Locations

Country Name City State
Egypt Faculty of Medicine Assuit University Assiut Assuit
Egypt Seham Mohamed Moeen Ibrahim Asyut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Quality of surgical field The surgeon will assess the quality of surgical field every 15 min after the beginning of drug infusion for the first 60 min according to a 6-point Boezaart scale intraoperative assessment
Secondary Surgeon satisfaction with a 4-point scale: 1 = Poor, 2 = Moderate, 3 = Good, 4 = Excellent At the end of surgery
Secondary Mean arterial pressure Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion intraoperative assessment
Secondary Heart rate Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion intraoperative assessment
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