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Nasal DiseaseNCT06867302

Dexmedetomidine and Agitation After Nasal Surgery

A study testing Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) and Dexmedetomidine Injection [Precedex] in people with Nasal Disease and Agitation, Emergence, run by Fayoum University Hospital at 1 site in Egypt.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Nasal Disease, Agitation, Emergence
What is being tested?
Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) and Dexmedetomidine Injection [Precedex]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Aug 2025to 1 Dec 2026
Phase
Interventional

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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • American Society of Anesthesiologist (ASA) Ⅰ or II
  • Adults with body mass index (BMI) < 30 Kg/m
  • Underwent elective nasal surgery.

Who cannot join

  • Significant comorbidity like hepatic, renal, or cardiac disease
  • Auditory impairment
  • Cognitive dysfunction
  • Substance abuse
  • Allergy to the studied medicines
  • Planned intensive care admission after the surgery.

Trial locations and contacts

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

Yasser S Mostafa, MD contact

01010509735 ext. +2

ysm03@fayoum.edu.eg

Mohamed A Shawky, MD contact

0 109 525 4547 ext. +2

mas14@fayoum.edu.eg

Egypt1 site, 1 recruiting
  • Fayoum University Hospital

    Al Fayyum, Faiyum Governorate, 63514

    Yasser S Mostafa, MD., 01010509735 ext. +2, ysm03@fayoum.edu.eg

    Mohamed A Shawky, MD, 01095254547 ext. +2, mas14@fayoum.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Effectiveness of Single Bolus Versus Continuous Infusion of Dexmedetomidine in Mitigating Agitation in Adults Undergoing Nasal Surgery: a Prospective Randomized Trial

The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.

Read the detailed description

Agitation during emergence from general anesthesia is a potentially serious phenomenon that has not been studied in adults as often as in pediatric population. When agitation, serious self-injury, or violence towards the medical team occur, with the risk of aspiration, bleeding, hypoxia, arrhythmias, or simply pulling the endotracheal tubes, removal of drains or catheters. Moreover, agitated patients are not only at risk of developing complications but also, they are labor intensive as they require more medical attention, rescue drugs, and more attending staff till agitation attack safely subside. Recognized risk factors to develop emergence agitation (EA) in adults include ear, nose, and throat surgery, obesity, sevoflurane anesthesia, endotracheal tube, and history of psychological illness. In adults, adjuvants have been co-administered with general anesthesia in order to negate or reduce the incidence of EA especially in patients with identified risk factors.

dexmedetomidine is a highly selective α2 sympatholytic, has been proposed as an attractive candidate for the prophylaxis of EA. By interacting with α2 receptors in locus coeruleus of the pons, Dex exerts its unique anxiolytic, sedative and sympathetic antagonistic action with no respiratory depression. Moreover, it has pain-modulating effect due to interaction with α2 receptor sites in the dorsal horn and supra-spinal regions.

Nevertheless, there have been conflicting data about Dex optimal dose and time of administration when used as prophylaxis against EA. Indeed, different dosing protocols are associated with over sedation, prolonged extubation time, and delayed post-anaesthesia care unit time.

No premedication. Basic general anesthesia monitoring included electrocardiogram, pulse oximetry, non-invasive arterial pressure, and capnography, were recorded every 5 min. Preoxygenation with 100% oxygen for 5 min was performed before fentanyl 1 μg/kg and propofol 1.5-2 mg/ kg, were administered as induction agents. Intubation with facilitated with atracurium besylate 0.5 mg/ kg. The size of endotracheal tubes was 6.5-7.5 mm, for females and males, respectively. Mechanical ventilation was set on 6 ml/kg tidal volume, and respiratory rate was adjusted to keep end-tidal CO2 between 35 and 40 mmHg, in 50% O2/air. All patients at induction were given dexamethasone 4 mg i.v., ondansetron, 4 mg i.v to prevent post-operative nausea and vomiting, plus Ringers lactate solution 6 mg/ kg drip for basic volume maintenance. Blood loss was compensated for with Ringers lactate, intraoperatively. Maintenance of anesthesia was carried out with Isoflurane, regulated at 2-3%, Titrated incremental doses of atropine 0.5 mg, esmolol 10 mg, and ephedrine 6 mg were given i.v., when HR ≤ 45, HR ≥ 120 and MAP ≤ 60, in the mentioned order. ketorolac 30 mg was given I.M., at the time of nasal packing.

When surgery was finished, gentle suction was attempted, non-depolarizing muscle relaxant reverse with atropine, 0.5 mg and neostigmine 0.02 mg/kg was given. Next, isoflurane was turned off and respiration was then converted back to manual ventilation with 100% oxygen at 7 L/min. The patients were not disturbed, except by continual verbal requests to open their eyes. All other stimuli were prevented. Extubation was done when patients were able to breathe spontaneously and interact with verbal demands. When patients were awake, calm, and sedated, they were transferred to the PACU. Patients were discharged from the PACU when their Aldrete score was ≥ 9.

Statistical analysis:

Statistical analysis will be conducted using IBM SPSS Statistics 22 (IBM Corporation, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p < 0.05 will be deemed to be statistically significant.

Being tested
Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML), Dexmedetomidine Injection [Precedex]
Keywords
Dexmedetomidine, Emergence agitation, Nasal surgery
Medical subject headings
Nose Diseases, Emergence Delirium

What participants receive

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

  • Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Drug

    Also called Dexmedetomidine infusion

    An infusion given all through intraoperative time

  • Dexmedetomidine Injection [Precedex]Drug

    Also called Dexmedetomidine bolus

    Single dose given 15 minutes before end of surgery

Study groups in NCT06867302
Study groupRoleWhat they receive
Bolus groupExperimentalsingle dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery
Receives: Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)
Infusion groupExperimentalInfusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time
Receives: Drug: Dexmedetomidine Injection [Precedex]

What is being measured

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

  1. Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)

    RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation

    Measured: 5 minutes after operation

Secondary outcomes (13)
  1. Intraoperative heart rate

    Beats / minute

    Measured: Every 15 minutes along operation

  2. Intraoperative mean arterial blood pressure

    mmHg

    Measured: Every 15 minutes along operation

  3. Time of first rescue analgesic

    in minutes in minutes

    Measured: 5 minutes before first analgesic request

  4. Extubation time

    time interval between shutting off anesthetics to extubation (in minutes)

    Measured: 3 minutes after removal of endotracheal tube

  5. Postanesthesia care unit time

    time interval from admission to PACU till patient scored ≥ 9 on Aldrete scale (ready to discharge)

    Measured: 5 minutes after discharge from recovery unit

  6. Incidence of use of midazolam

    Yes or no

    Measured: 2 minutes after occurence of emergence agitation

  7. Numerical rating score (NRS)

    10 point scale where zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Measured: Every 10 min in postanesthesia care unit

  8. Total amount of rescue analgesic

    in milligram

    Measured: 24 hours postoperative

  9. Boezaart Surgical Field Grading Scale

    endoscopically using the six-point score (0-5 Scale) where 0 - No bleeding, 1 - Slight bleeding, no suctioning needed, 2 - Slight bleeding, occasional suctioning needed, 3 - Moderate bleeding, frequent suctioning needed, visibility maintained, 4 - Heavy bleeding, constant suctioning needed, visibility impaired, 5 - Severe bleeding, uncontrolled, surgery impossible

    Measured: 2 hours intraoperatively

  10. Incidence of bradycardia

    Yes or no

    Measured: 2 hours intraoperatively

  11. Incidence of hypotension

    Yes or no when mean arterial blood pressure below 60 mmHg

    Measured: 2 hours intraoperatively

  12. Incidence of nausea

    Yes or no

    Measured: 24 hours postoperative

  13. Incidence of vomiting

    Yes or no

    Measured: 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 posted10 Mar 2025
  2. Study start1 Aug 2025
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Dec 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
Model description
the patients will be randomly allocated into two groups based on a computerized randomization table created by a researcher who was not involved in the study. The researcher assigned a random ID to each patient, and a blinded anesthesiologist used this ID while collecting the postoperative data in the surgical ward.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06867302
Sponsor's protocol ID
R656
Status last verified
Sep 2026
First submitted
4 Mar 2025
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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
  • Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.

    PubMed 19326585
  • Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.

    PubMed 25729495
  • Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.

    PubMed 16670111
  • Zhu M, Wang H, Zhu A, Niu K, Wang G. Meta-analysis of dexmedetomidine on emergence agitation and recovery profiles in children after sevoflurane anesthesia: different administration and different dosage. PLoS One. 2015 Apr 13;10(4):e0123728. doi: 10.1371/journal.pone.0123728. eCollection 2015.

    PubMed 25874562

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