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
The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.
Endoscopic sinus surgery (ESS) is a common operation for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) when medical therapy alone is insufficient .
Early recovery from general anesthesia is accompanied by agitation, confusion, disorientation, and violent behavior, which is known as Emergence Agitation (EA). This post-anesthetic issue occurs in the early stages of General Anesthesia (GA) recovery, posing challenges in terms of both patient recovery delay and the complexities associated with assessment and management.
The incidence of EA varies, from approximately 0.25% to 90.5%, with age, assessment tool used, definitions, anesthetic techniques, type of surgery, and time of EA assessment during recovery .
Because the airway is contaminated with blood and the nasal airway is closed with surgical packs. ENT surgery is linked to a higher incidence of emerging agitation after nasal surgery.
Although EA is commonly self-limited and happens within the first 30 min of stay in a postanesthesia care unit (PACU) and also can lead to disconnection of monitoring devices or intravenous catheters, physical damage, falling, increase in the risk of bleeding, and self-extubation .
Several pharmacological methods have been used to mitigate EA, including opioid (fentanyl, remifentanil), propofol, benzodiazepine (midazolam), α2- aderenoreceptor agonist (clonidine, dexmedetomidine), and N-methy-d-aspar- tate (NMDA) receptor antagonist (ketamine, magnesium sulfate) administration.
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. Systemic lidocaine has been shown to be an effective adjunct strategy to reduce postoperative pain.
Dexmedetomidine is known as a highly selective α (2)-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, and analgesic-sparing effects, which causes minimal depression of the respiratory function.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Active Comparator | Active comparator group Group (L) recieves IV lidocaine 1.5mg/kg slowly before induction of anesthesia then lidocaine infusion starts at a rate of 2mg/kg/h |
|
| Group D | Active Comparator | Active comparator group (D) recieves IV dexmedetomidine bolus dose of 1mcg/kg over 10 minutes before induction of anesthesia followed by continous infusion at 0.4mcg/kg/h until the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Group (D) recieves Dexmedetomidine bolus 1mcg/kg over 10 minutes before induction of anesthesia followed by continous infusion at 0.4 mcg/kg/h until the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of emergence agitation (EA) . | Incidence of emergence agitation (EA) as measured by Richmond Agitation Sedation Scale (RASS) . | Immediate after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate (beats per minute ) | heart rate (beats per minute ) was measured using standard ECG monitoring | baseline ( preoperative ) |
| heart rate (beats per minute ) | heart rate (beats per minute ) was measured using standard ECG monitoring |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khaled E Tolba, MBBCH | Contact | 01002568304 | ket11@fayoum.edu.eg | |
| Mohamed A Hamed, MD | Contact | 01010509736 |
| Name | Affiliation | Role |
|---|---|---|
| Khaled E Tolba, MBBCH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FayoumU | Al Fayyum | 63511 | Egypt |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25535538 | Result | Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90. | |
| 35012708 | Result | Lourijsen ES, Reitsma S, Vleming M, Hannink G, Adriaensen GFJPM, Cornet ME, Hoven DR, Videler WJM, Bretschneider JH, Reinartz SM, Rovers MM, Fokkens WJ. Endoscopic sinus surgery with medical therapy versus medical therapy for chronic rhinosinusitis with nasal polyps: a multicentre, randomised, controlled trial. Lancet Respir Med. 2022 Apr;10(4):337-346. doi: 10.1016/S2213-2600(21)00457-4. Epub 2022 Jan 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lidocaine | Drug | Group (L) recieves IV lidocaine 1.5 mg/kg slowly before induction of anesthesia then lidocaine infusion starts at a rate of 2mg/kg/h |
|
| after 30 minutes ( intraoperative) |
| heart rate (beats per minute) | heart rate (beats per minute ) was measured using standard ECG monitoring | after 60 minutes ( intraoperative ) |
| heart rate (beats per minute) | heart rate (beats per minute ) was measured using standard ECG monitoring | 0 hour postoperative |
| heart rate (beats per minute) | heart rate (beats per minute ) was measured using standard ECG monitoring | 1 hour postoperative |
| heart rate (beats per minute) | heart rate (beats per minute ) was measured using standard ECG monitoring | 3 hours postoperative |
| heart rate (beats per minute) | heart rate (beats per minute ) was measured using standard ECG monitoring | 6 hours postoperative |
| heart rate (beats per minute) | heart rate (beats per minute ) was measured using standard ECG monitoring | 12 hours postoperative |
| heart rate (beats per minute) | heart rate (beats per minute ) was measured using standard ECG monitoring | 24 hours postoperative |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | baseline ( preoperative ) |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | after 30 minutes ( intraoperative ) |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | after 60 minutes ( intraoperative ) |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | 0 hour post operative |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | 1 hour post operative |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | 3 hour post operative |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | 6 hour post operative |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | 12 hour post operative |
| Mean arterial blood pressure (mmHg) | MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring . | 24 hour post operative |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | baseline ( preoperative ) |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | after 30 minutes ( intraoperative ) |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | after 60 minutes ( intraoperative) |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | 0 hour post operative |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | 1 hour post operative |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | 3 hour post operative |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | 6 hour post operative |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | 12 hour post operative |
| Peripheral oxygen saturation (SpO2, %) | Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry | 24 hour post operative |
| Postoperative pain score | Postoperative pain was assessed using the Numeric rating scale (NRS) , ranging from 0 ( no pain ) to 10 ( worst imaginable pain ) | 0, 1 h(hour), 3h, 6h, 12h, 24h postoperatively |
| Incidence of adverse events | Incidence of adverse events including postoperative nausea&vomiting , allergy , bradycardia (HR<50) , hypotension (MAP decreases by >20%) , desaturation ( SpO2<92%) | first 24 hours postoperative |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |