Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Active Comparator | IV Lidocaine infusion |
|
| Control | Placebo Comparator | IV normal saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | IV Lidocaine infusion |
| |
| Normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Surgeon satisfaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seham M Moeen, MD | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Assuit University | Asyut | Assuit | 71111 | Egypt | ||
| Seham Mohamed Moeen Ibrahim |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
IV normal saline infusion |
|
with a 4-point scale: 1 = Poor, 2 = Moderate, 3 = Good, 4 = Excellent
| At the end of surgery |
| 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 |
| 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 |
| Asyut |
| 71111 |
| Egypt |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |