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NCT Number: NCT06867302

Dexmedetomidine and Agitation After Nasal Surgery

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Drug

An infusion given all through intraoperative time

Other names: Dexmedetomidine infusion

Dexmedetomidine Injection [Precedex]

Drug

Single dose given 15 minutes before end of surgery

Other names: Dexmedetomidine bolus

Primary outcomes

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

    Time frame: 5 minutes after operation

    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

Secondary outcomes

  1. Intraoperative heart rate

    Time frame: Every 15 minutes along operation

    Beats / minute

  2. Intraoperative mean arterial blood pressure

    Time frame: Every 15 minutes along operation

    mmHg

  3. Time of first rescue analgesic

    Time frame: 5 minutes before first analgesic request

    in minutes in minutes

  4. Extubation time

    Time frame: 3 minutes after removal of endotracheal tube

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

  5. Postanesthesia care unit time

    Time frame: 5 minutes after discharge from recovery unit

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

  6. Incidence of use of midazolam

    Time frame: 2 minutes after occurence of emergence agitation

    Yes or no

  7. Numerical rating score (NRS)

    Time frame: Every 10 min in postanesthesia care unit

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

  8. Total amount of rescue analgesic

    Time frame: 24 hours postoperative

    in milligram

  9. Boezaart Surgical Field Grading Scale

    Time frame: 2 hours intraoperatively

    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

  10. Incidence of bradycardia

    Time frame: 2 hours intraoperatively

    Yes or no

  11. Incidence of hypotension

    Time frame: 2 hours intraoperatively

    Yes or no when mean arterial blood pressure below 60 mmHg

  12. Incidence of nausea

    Time frame: 24 hours postoperative

    Yes or no

  13. Incidence of vomiting

    Time frame: 24 hours postoperative

    Yes or no

Other outcomes

  1. Age

    Time frame: 5 minutes before entering operation department

    in years

  2. Sex

    Time frame: 5 minutes before entering operation department

    Male of female

  3. Weight

    Time frame: 5 minutes before entering operation department

    In kilogram

  4. Height

    Time frame: 5 minutes before entering operation department

    In centimeter

  5. Duration of surgery

    Time frame: 5 minutes after end of surgery

    In minutes

Study contacts

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

Mohamed A Shawky, MD

CONTACT

[email protected]

0 109 525 4547 ext. +2

Yasser S Mostafa, MD

CONTACT

[email protected]

01010509735 ext. +2

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

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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