FayoumU
Al Fayyum, 63511, Egypt
Location contact
Khaled E Tolba, MBBCH
CONTACT
Khaled E Tolba, MBBCH
PRINCIPAL_INVESTIGATOR
Mohamed A Hamed, MD
CONTACT
NCT Number: NCT07355049
The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Al Fayyum, 63511, Egypt
Khaled E Tolba, MBBCH
CONTACT
Khaled E Tolba, MBBCH
PRINCIPAL_INVESTIGATOR
Mohamed A Hamed, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Immediate after extubation
Incidence of emergence agitation (EA) as measured by Richmond Agitation Sedation Scale (RASS) .
Time frame: baseline ( preoperative )
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: after 30 minutes ( intraoperative)
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: after 60 minutes ( intraoperative )
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: 0 hour postoperative
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: 1 hour postoperative
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: 3 hours postoperative
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: 6 hours postoperative
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: 12 hours postoperative
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: 24 hours postoperative
heart rate (beats per minute ) was measured using standard ECG monitoring
Time frame: baseline ( preoperative )
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: after 30 minutes ( intraoperative )
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: after 60 minutes ( intraoperative )
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: 0 hour post operative
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: 1 hour post operative
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: 3 hour post operative
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: 6 hour post operative
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: 12 hour post operative
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: 24 hour post operative
MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Time frame: baseline ( preoperative )
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: after 30 minutes ( intraoperative )
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: after 60 minutes ( intraoperative)
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: 0 hour post operative
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: 1 hour post operative
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: 3 hour post operative
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: 6 hour post operative
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: 12 hour post operative
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: 24 hour post operative
Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Time frame: 0, 1 h(hour), 3h, 6h, 12h, 24h postoperatively
Postoperative pain was assessed using the Numeric rating scale (NRS) , ranging from 0 ( no pain ) to 10 ( worst imaginable pain )
Time frame: first 24 hours postoperative
Incidence of adverse events including postoperative nausea&vomiting , allergy , bradycardia (HR<50) , hypotension (MAP decreases by >20%) , desaturation ( SpO2<92%)
Contact information is provided by the study sponsor or research team.
Fayoum University
Other
The Effect of Intravenous Dexmedetomidine Versus Intravenous Lidocaine on the Emergence Agitation After Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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