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This work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.
Sinus surgery is one of the most prevalent surgeries on the ear, nose, and throat (ENT). It is mainly carried out through endoscopy and significantly improves the clinical symptoms of patients with rhinosinusitis. Safe conditions must be maintained for this surgery, and the major problem reported during functional endoscopic sinus surgery (FESS) under general anesthesia (GA) is impaired visibility due to excessive bleeding.
Dexmedetomidine is an α2-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, analgesic-sparing effects and minimal depression of respiratory function. It is potent and highly selective for α2-receptors.
Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life and a favorable safety profile and is,, therefore,, the LA of choice for continuous IV administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine group | Experimental | Patients will receive lidocaine (1.5 mg/kg loading then 1mg/kg/h infusion) just after induction of anesthesia induction and continued until the end of the operation. |
|
| Dexmedetomidine group | Experimental | Patients will receive 1 μg/kg dexmedetomidine infusion over 10 min as a loading dose then 0.4-0.7 μg/kg/h just after induction of anesthesia induction and continued until the end of the operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Patients will receive lidocaine (1.5 mg/kg loading then 1mg/kg/h infusion) just after induction of anesthesia induction and continued until the end of the operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical field | Surgical field will be assessed by Fromme et al. scale. (0-no bleeding, 1-slight bleeding, no suctioning of blood required, 2-slight bleeding occasional suctioning required, surgical field not threatened, 3-slight bleeding - frequent suctioning required. Bleeding threatens surgical field as few seconds after suction will be removed, 4-moderate bleeding - frequent suctioning required, bleeding threatens surgical field directly after suction will be removed, 5-severe bleeding - constant suctioning required, bleeding appeared faster than removed by suction. The surgical field severely threatened, and surgery not possible). The ideal category scale value will be determined to be ≤3. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the Visual Analogue Scale (VAS)< 4. VAS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 12, 18, and 24h postoperatively. | 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Eldemerdash, MD | Contact | 00201114959206 | ahmedmonier@med.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | 11591 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Dexmedetomidine | Drug | Patients will receive 1 μg/kg dexmedetomidine infusion over 10 min as a loading dose then 0.4-0.7 μg/kg/h just after induction of anesthesia induction and continued until the end of the operation. |
|
| Heart rate |
Heart rate will be recorded before induction, every 5 minutes for the first 20 minutes, then every 15 minutes until the end of the surgery. |
| Till the end of surgery (Up to 4 hours) |
| Mean arterial pressure | Mean arterial pressure will be recorded before induction, every 5 minutes for the first 20 minutes, then every 15 minutes until the end of the surgery. | Till the end of surgery (Up to 4 hours) |
| Time to the first request for the rescue analgesia. | Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated). | 24 hours postoperatively |
| Degree of pain | The degree of pain will be assessed using the Visual Analogue Scale (VAS). (VAS 0 represents "no pain," while 10 represents "the worst pain imaginable.") VAS will be assessed at the post-anesthesia care unit (PACU), 2, 4, 6, 12, 18, and 24h postoperatively. | 24 hours postoperatively |
| Degree of patient satisfaction | Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied). | 24 hours postoperatively |
| Incidence of adverse events | Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, upper airway obstruction, respiratory depression, emergence agitation, and postoperative awareness or any other complication will be recorded. | 24 hours postoperatively |
| Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |