Dexmedetomidine, Functional Endoscopic Sinus Surgery, Infusion, Intraoperative Bleeding, Lidocaine
Conditions
Brief summary
This work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.
Detailed description
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.
Interventions
DRUGLidocaine
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.
DRUGDexmedetomidine
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years old. * American Society of Anesthesiologists (ASA) physical status I - II. * Scheduled for elective functional endoscopic sinus surgery.
Exclusion criteria
* Diabetes mellitus. * Coagulation disorders. * Kidney and liver dysfunction. * Cerebrovascular disease. * Cardiovascular problems. * High blood pressure. * Asthma. * Chronic obstructive pulmonary disease (COPD). * End organ damage. * Psychosis. * Taking antipsychotic drugs. * Allergy to study drugs. * Substance abuse. * Taking beta blockers. * Heart rate of \< 55 beat/minute.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical field | Intraoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 24 hours postoperatively | 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. |
| Heart rate | Till the end of surgery (Up to 4 hours) | 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. |
| Mean arterial pressure | Till the end of surgery (Up to 4 hours) | 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. |
| Time to the first request for the rescue analgesia. | 24 hours postoperatively | Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated). |
| Degree of pain | 24 hours postoperatively | 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. |
| Degree of patient satisfaction | 24 hours postoperatively | 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). |
| Incidence of adverse events | 24 hours postoperatively | 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. |
Countries
Egypt
Outcome results
None listed