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Emergence AgitationNCT07302815

Preemptive Intravenous Micro-dose Dexmedetomidine to Prevent Emergence Agitation in Adult Patients Undergoing Septoplasty Surgeries

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries 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 Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteEgypt
Study dates
10 Jan 2026to 20 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • Adult patients of both gender aged 18 to 60 years with American Society of Anesthesiologists (ASA) Physical Status I or II, who were scheduled for septoplasty surgery under general anesthesia.

Who cannot join

  • Patients declined to participate in the trial.
  • History or clinical evidence of chronic obstructive pulmonary disease.
  • History of renal or hepatic dysfunction, sleep apnea syndrome.
  • Cognitive dysfunction or psychiatric disorder.
  • Patients receiving beta blocker.
  • Patients with anticipated difficult airway.
Show all 9Show fewer
  • Patients with electro cardiac abnormalities.
  • Emergency surgeries.
  • Pregnancy.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta university

    Tanta, Gharbia Governorate, 31527

Other trials in Egypt

About this study

Official title: Preemptive Intravenous Micro-dose Dexmedetomidine to Prevent Emergence Agitation in Adult Patients Undergoing Septoplasty Surgeries: A Randomized Placebo Controlled Study

This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries

Read the detailed description

Emergence agitation (EA) is characterised by confusion, restlessness or aggressive behaviour during recovery from general anaesthesia. EA is more common following ear, nose, \& throat (ENT) surgery. The exact cause and pathophysiology of EA are unknown, although risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, otolaryngology operations, and the use of inhalational anesthetics particularly sevoflurane. EA might cause injury, accidental removal of intravenous cannulation, self-extubation, post-operative wound bleeding and increase the nursing requirements in the post-anesthesia care unit (PACU). There are limited studies concerning adult EA, and although its prevalence is less than child EA, it carries more risk of injury due to serious uncontrolled behaviors. Intravenous (IV) anesthetics, sedatives and opioids are the most frequently utilized medications to manage EA, with variable success rates and significant potential to delay recovery and cause undesirable side-effects. Dexmedetomidine is a highly selective α2 agonist which produces sedation and anxiolysis through reduction in sympathetic central nervous system activity. It has a major advantage over other sedatives; it is associated with minimal respiratory depression. According to a recent meta-analysis, intraoperative administration of dexmedetomidine decreases postoperative pain and the incidence of EA in adults. Considering the short length of corrective nasal reduction surgery (CR), an intraoperative infusion of dexmedetomidine as an anesthetic adjuvant may prolong the anesthesia and recovery time. Low dose infusion of dexmedetomidine (0.2 µg /kg/h) has been reported to reduce incidence of EA and opioid consumption effectively in elderly patients undergoing cancer surgeries under GA. Previous studies have shown that a single dose of dexmedetomidine, not as a premedication, is also effective in reducing EA and facilitating smooth extubation after pediatric adenotonsillectomy. Also recent study reported the efficacy of pre-operative dexmedetomidine administration (1 μg/kg) in preventing EA in adults undergoing CR of a nasal bone fracture. Up till now no clinical studies investigated the efficacy of single pre-operative micro dose of dexmedetomidine in prevention of EA, so in this clinical study we hypothesize that preoperative micro dose of dexmedetomidine may be beneficial in mitigation of EA in short timed Septoplasty surgeries safely and without prolongation of recovery time.

Being tested
Dexmedetomidine, Saline
Keywords
Emergence agitation, septoplasty surgeries, micro-dose Dexmedetomidine
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

    micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

  • SalineDrug

    50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

Study groups in NCT07302815
Study groupRoleWhat they receive
Dexmedetomidine groupExperimental60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.
Receives: Drug: Dexmedetomidine
Control groupPlacebo comparator60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.
Receives: Drug: Saline

What is being measured

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

  1. Incidence of emergence agitation

    using Aono's Four-Point Scale (Aono Scale) which is a simple and widely used tool to assess emergence agitation (EA). It categorizes agitation during emergence from anesthesia into four levels.

    1. calm_ Patient is quiet and not agitated.
    2. Not calm but can be easily consoled _ Slight restlessness but settles with verbal reassurance or mild physical comfort.
    3. Moderately agitated _ Patient is crying or difficult to console but not combative.
    4. Severely agitated _Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

    Scores 3-4 indicate clinically relevant emergence agitation.

    Measured: incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

Secondary outcomes (5)
  1. severity of emergence agitation

    Aono's Scale grades the intensity of a patient's agitation during emergence from anesthesia (3) Moderately agitated - Patient is crying or difficult to console but not combative.

    (4) Severely agitated - Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

    Measured: severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

  2. extubation time

    Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

    Measured: Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

  3. Length of stay in the post anesthetic care unit (PACU).

    Total time a patient spends in the PACU from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

    Measured: time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

  4. Intraoperative opioid consumption

    Total amount of opioid medications administered to a patient during the entire surgical procedure, from induction of anesthesia until completion of surgery

    Measured: from induction of anesthesia until completion of surgery

  5. Post operative numerical rating scale score (NRS)

    The Numerical Rating Scale (NRS) is a validated tool used to assess a patient's pain intensity by having them assign a number to their pain on a 0-10 scale.

    On a scale from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable

    Measured: - NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery

Timeline

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

  1. First posted24 Dec 2025
  2. Study start10 Jan 2026
  3. Primary completion20 Aug 2026
  4. Study completion20 Aug 2026

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
Model description
parallel assignment
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07302815
Sponsor's protocol ID
36264PR131061/11/25
Status last verified
Dec 2025
First submitted
11 Dec 2025
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be available upon a reasonable request from the corresponding author

Publications

  • Kim JC, Kim J, Kwak H, Ahn SW. Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 7;19(1):144. doi: 10.1186/s12871-019-0816-5.

    PubMed 31391001
  • Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.

    PubMed 16101707
  • Lee HS, Yoon HY, Jin HJ, Hwang SH. Can Dexmedetomidine Influence Recovery Profiles from General Anesthesia in Nasal Surgery? Otolaryngol Head Neck Surg. 2018 Jan;158(1):43-53. doi: 10.1177/0194599817733735. Epub 2017 Sep 26.

    PubMed 28949804
  • Abdelaziz TSA, Mohammed Elsayed HE, Kamal Eldin DM, Ibrahim IM. "The effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty". A prospective, randomized, double-blind controlled trial. BMC Anesthesiol. 2025 Jan 31;25(1):50. doi: 10.1186/s12871-025-02914-5.

    PubMed 39891093
  • Zhu W, Sun J, He J, Zhang W, Shi M. A Randomized Controlled Study of Caudal Dexmedetomidine for the Prevention of Postoperative Agitation in Children Undergoing Urethroplasty. Front Pediatr. 2021 Sep 29;9:658047. doi: 10.3389/fped.2021.658047. eCollection 2021.

    PubMed 34660472
  • Al Mutair A, Alabbasi Y, Alshammari B, Alrasheeday AM, Alharbi HF, Aleid AM. A Meta-Analysis of the Impact of Intranasal Dexmedetomidine on Emergence Delirium and Agitation in Children and Adolescents Undergoing Tonsillectomy and/or Adenoidectomy. J Clin Med. 2025 Feb 26;14(5):1586. doi: 10.3390/jcm14051586.

    PubMed 40095538
  • Cole JW, Murray DJ, McAllister JD, Hirshberg GE. Emergence behaviour in children: defining the incidence of excitement and agitation following anaesthesia. Paediatr Anaesth. 2002 Jun;12(5):442-7. doi: 10.1046/j.1460-9592.2002.00868.x.

    PubMed 12060332
  • Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.

    PubMed 20526708
  • Tolly B, Waly A, Peterson G, Erbes CR, Prielipp RC, Apostolidou I. Adult Emergence Agitation: A Veteran-Focused Narrative Review. Anesth Analg. 2021 Feb 1;132(2):353-364. doi: 10.1213/ANE.0000000000005211.

    PubMed 33177329

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine and Saline in people with Emergence Agitation, run by Tanta 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 6 Oct 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of emergence agitation (time frame: incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.). 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 NCT07302815, which also lists 9 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 6 Oct 2026.

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