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The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation.

The Effect of Intravenous Dexmedetomidine Versus Intravenous Lidocaine on the Emergence Agitation After Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07355049
Enrollment
80
Registered
2026-01-21
Start date
2025-12-21
Completion date
2026-02-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

Keywords

Emergence agitation, Intravenous dexmedetomidine, Endoscopic sinus surgery, Intravenous lidocaine

Brief summary

The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.

Detailed description

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.

Interventions

DRUGDexmedetomidine

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

DRUGLidocaine

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

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age : 18-60 * ASA Physical Status I or II * Elective endoscopic sinus surgery under general anesthesia .

Exclusion criteria

* Refusal to participate * Mental retardation or inability to communicate * Allergy to anesthetics or study medications . * Chronic use of beta blockers . * significant hepatic, neurologic, cardiovascular or respiratory disease . * BMI\>35 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
Incidence of emergence agitation (EA) .Immediate after extubationIncidence of emergence agitation (EA) as measured by Richmond Agitation Sedation Scale (RASS) .

Secondary

MeasureTime frameDescription
heart rate (beats per minute )baseline ( preoperative )heart rate (beats per minute ) was measured using standard ECG monitoring
Mean arterial blood pressure (mmHg)baseline ( preoperative )MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .
Peripheral oxygen saturation (SpO2, %)baseline ( preoperative )Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry
Postoperative pain score0, 1 h(hour), 3h, 6h, 12h, 24h postoperativelyPostoperative pain was assessed using the Numeric rating scale (NRS) , ranging from 0 ( no pain ) to 10 ( worst imaginable pain )
Incidence of adverse eventsfirst 24 hours postoperativeIncidence of adverse events including postoperative nausea\&vomiting , allergy , bradycardia (HR\<50) , hypotension (MAP decreases by \>20%) , desaturation ( SpO2\<92%)
heart rate (beats per minute)after 60 minutes ( intraoperative )heart rate (beats per minute ) was measured using standard ECG monitoring

Countries

Egypt

Contacts

CONTACTKhaled E Tolba, MBBCH
ket11@fayoum.edu.eg01002568304
CONTACTMohamed A Hamed, MD
01010509736
PRINCIPAL_INVESTIGATORKhaled E Tolba, MBBCH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026