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NCT Number: NCT07355049

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Incidence of emergence agitation (EA) .

    Time frame: Immediate after extubation

    Incidence of emergence agitation (EA) as measured by Richmond Agitation Sedation Scale (RASS) .

Secondary outcomes

  1. heart rate (beats per minute )

    Time frame: baseline ( preoperative )

    heart rate (beats per minute ) was measured using standard ECG monitoring

  2. heart rate (beats per minute )

    Time frame: after 30 minutes ( intraoperative)

    heart rate (beats per minute ) was measured using standard ECG monitoring

  3. heart rate (beats per minute)

    Time frame: after 60 minutes ( intraoperative )

    heart rate (beats per minute ) was measured using standard ECG monitoring

  4. heart rate (beats per minute)

    Time frame: 0 hour postoperative

    heart rate (beats per minute ) was measured using standard ECG monitoring

  5. heart rate (beats per minute)

    Time frame: 1 hour postoperative

    heart rate (beats per minute ) was measured using standard ECG monitoring

  6. heart rate (beats per minute)

    Time frame: 3 hours postoperative

    heart rate (beats per minute ) was measured using standard ECG monitoring

  7. heart rate (beats per minute)

    Time frame: 6 hours postoperative

    heart rate (beats per minute ) was measured using standard ECG monitoring

  8. heart rate (beats per minute)

    Time frame: 12 hours postoperative

    heart rate (beats per minute ) was measured using standard ECG monitoring

  9. heart rate (beats per minute)

    Time frame: 24 hours postoperative

    heart rate (beats per minute ) was measured using standard ECG monitoring

  10. Mean arterial blood pressure (mmHg)

    Time frame: baseline ( preoperative )

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  11. Mean arterial blood pressure (mmHg)

    Time frame: after 30 minutes ( intraoperative )

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  12. Mean arterial blood pressure (mmHg)

    Time frame: after 60 minutes ( intraoperative )

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  13. Mean arterial blood pressure (mmHg)

    Time frame: 0 hour post operative

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  14. Mean arterial blood pressure (mmHg)

    Time frame: 1 hour post operative

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  15. Mean arterial blood pressure (mmHg)

    Time frame: 3 hour post operative

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  16. Mean arterial blood pressure (mmHg)

    Time frame: 6 hour post operative

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  17. Mean arterial blood pressure (mmHg)

    Time frame: 12 hour post operative

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  18. Mean arterial blood pressure (mmHg)

    Time frame: 24 hour post operative

    MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .

  19. Peripheral oxygen saturation (SpO2, %)

    Time frame: baseline ( preoperative )

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  20. Peripheral oxygen saturation (SpO2, %)

    Time frame: after 30 minutes ( intraoperative )

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  21. Peripheral oxygen saturation (SpO2, %)

    Time frame: after 60 minutes ( intraoperative)

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  22. Peripheral oxygen saturation (SpO2, %)

    Time frame: 0 hour post operative

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  23. Peripheral oxygen saturation (SpO2, %)

    Time frame: 1 hour post operative

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  24. Peripheral oxygen saturation (SpO2, %)

    Time frame: 3 hour post operative

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  25. Peripheral oxygen saturation (SpO2, %)

    Time frame: 6 hour post operative

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  26. Peripheral oxygen saturation (SpO2, %)

    Time frame: 12 hour post operative

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  27. Peripheral oxygen saturation (SpO2, %)

    Time frame: 24 hour post operative

    Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry

  28. Postoperative pain score

    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 )

  29. Incidence of adverse events

    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%)

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled E Tolba, MBBCH

CONTACT

[email protected]

01002568304

Mohamed A Hamed, MD

CONTACT

01010509736

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

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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