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Emergence AgitationNCT07355049

The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation.

A study testing Dexmedetomidine and Lidocaine in people with Emergence Agitation, run by Fayoum University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Emergence Agitation
What is being tested?
Dexmedetomidine and Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
21 Dec 2025to 1 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Khaled E Tolba, MBBCH contact

01002568304

ket11@fayoum.edu.eg

Mohamed A Hamed, MD contact

01010509736

Egypt1 site

  • FayoumU

    Al Fayyum, 63511

    Khaled E Tolba, MBBCH, 01002568304, ket11@fayoum.edu.eg

    Mohamed A Hamed, MD, 01010509736

Other trials in Egypt

About this study

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

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

Read the 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.

Keywords
Emergence agitation, Intravenous dexmedetomidine, Endoscopic sinus surgery, Intravenous lidocaine
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    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

  • LidocaineDrug

    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

Study groups in NCT07355049
Study groupRoleWhat they receive
Group LActive comparatorActive 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
Receives: Drug: Lidocaine
Group DActive comparatorActive 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
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of emergence agitation (EA) .

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

    Measured: Immediate after extubation

Secondary outcomes (29)

  1. heart rate (beats per minute )

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

    Measured: baseline ( preoperative )

  2. heart rate (beats per minute )

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

    Measured: after 30 minutes ( intraoperative)

  3. heart rate (beats per minute)

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

    Measured: after 60 minutes ( intraoperative )

  4. heart rate (beats per minute)

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

    Measured: 0 hour postoperative

  5. heart rate (beats per minute)

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

    Measured: 1 hour postoperative

  6. heart rate (beats per minute)

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

    Measured: 3 hours postoperative

  7. heart rate (beats per minute)

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

    Measured: 6 hours postoperative

  8. heart rate (beats per minute)

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

    Measured: 12 hours postoperative

  9. heart rate (beats per minute)

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

    Measured: 24 hours postoperative

  10. Mean arterial blood pressure (mmHg)

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

    Measured: baseline ( preoperative )

  11. Mean arterial blood pressure (mmHg)

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

    Measured: after 30 minutes ( intraoperative )

  12. Mean arterial blood pressure (mmHg)

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

    Measured: after 60 minutes ( intraoperative )

  13. Mean arterial blood pressure (mmHg)

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

    Measured: 0 hour post operative

  14. Mean arterial blood pressure (mmHg)

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

    Measured: 1 hour post operative

  15. Mean arterial blood pressure (mmHg)

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

    Measured: 3 hour post operative

  16. Mean arterial blood pressure (mmHg)

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

    Measured: 6 hour post operative

  17. Mean arterial blood pressure (mmHg)

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

    Measured: 12 hour post operative

  18. Mean arterial blood pressure (mmHg)

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

    Measured: 24 hour post operative

  19. Peripheral oxygen saturation (SpO2, %)

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

    Measured: baseline ( preoperative )

  20. Peripheral oxygen saturation (SpO2, %)

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

    Measured: after 30 minutes ( intraoperative )

  21. Peripheral oxygen saturation (SpO2, %)

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

    Measured: after 60 minutes ( intraoperative)

  22. Peripheral oxygen saturation (SpO2, %)

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

    Measured: 0 hour post operative

  23. Peripheral oxygen saturation (SpO2, %)

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

    Measured: 1 hour post operative

  24. Peripheral oxygen saturation (SpO2, %)

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

    Measured: 3 hour post operative

  25. Peripheral oxygen saturation (SpO2, %)

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

    Measured: 6 hour post operative

  26. Peripheral oxygen saturation (SpO2, %)

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

    Measured: 12 hour post operative

  27. Peripheral oxygen saturation (SpO2, %)

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

    Measured: 24 hour post operative

  28. Postoperative pain score

    Postoperative pain was assessed using the Numeric rating scale (NRS) , ranging from 0 ( no pain ) to 10 ( worst imaginable pain )

    Measured: 0, 1 h(hour), 3h, 6h, 12h, 24h postoperatively

  29. Incidence of adverse events

    Incidence of adverse events including postoperative nausea\&vomiting , allergy , bradycardia (HR<50) , hypotension (MAP decreases by >20%) , desaturation ( SpO2<92%)

    Measured: first 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start21 Dec 2025 (estimated)
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07355049
Sponsor's protocol ID
M786
Status last verified
Jan 2026
First submitted
15 Nov 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25535538

  • 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.

    PubMed 35012708

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine and Lidocaine in people with Emergence Agitation, run by Fayoum University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Khaled E Tolba, MBBCH (01002568304, ket11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of emergence agitation (EA) . (time frame: Immediate after extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07355049, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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