Dexmedetomidine and Agitation After Nasal Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Agitation, Emergence; Nasal Disease
• Intervention / Treatment: Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); Drug: Dexmedetomidine Injection [Precedex]

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasser S Mostafa, MD; Phone Number: +2 01010509735; Email: ysm03@fayoum.edu.eg
• Study Contact Backup: Name: Mohamed A Shawky, MD; Phone Number: +2 0 109 525 4547; Email: mas14@fayoum.edu.eg

Study Locations

• Egypt
  • Faiyum
    • Fayoum, Faiyum, Egypt, 63514
      • Recruiting
      • Fayoum University hospital
      • Contact: Yasser S Mostafa, MD.; Phone Number: +2 01010509735; Email: ysm03@fayoum.edu.eg
      • Contact: Mohamed A Shawky, MD; Phone Number: +2 01095254547; Email: mas14@fayoum.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bolus group; single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery	Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML); An infusion given all through intraoperative time; Other Names: Dexmedetomidine infusion
Experimental: Infusion group; Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time	Drug: Dexmedetomidine Injection [Precedex]; Single dose given 15 minutes before end of surgery; Other Names: Dexmedetomidine bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 minutes after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of nausea	Yes or no	24 hours postoperative
Incidence of vomiting	Yes or no	24 hours postoperative
Intraoperative heart rate	Beats / minute	Every 15 minutes along operation
Intraoperative mean arterial blood pressure	mmHg	Every 15 minutes along operation
Time of first rescue analgesic	in minutes in minutes	5 minutes before first analgesic request
Extubation time	time interval between shutting off anesthetics to extubation (in minutes)	3 minutes after removal of endotracheal tube
Postanesthesia care unit time	time interval from admission to PACU till patient scored ≥ 9 on Aldrete scale (ready to discharge)	5 minutes after discharge from recovery unit
Incidence of use of midazolam	Yes or no	2 minutes after occurence of emergence agitation
Numerical rating score (NRS)	10 point scale where zero meaning "no pain" and 10 meaning "the worst pain imaginable"	Every 10 min in postanesthesia care unit
Total amount of rescue analgesic	in milligram	24 hours postoperative
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	2 hours intraoperatively
Incidence of bradycardia	Yes or no	2 hours intraoperatively
Incidence of hypotension	Yes or no when mean arterial blood pressure below 60 mmHg	2 hours intraoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	in years	5 minutes before entering operation department
Sex	Male of female	5 minutes before entering operation department
Weight	In kilogram	5 minutes before entering operation department
Height	In centimeter	5 minutes before entering operation department
Duration of surgery	In minutes	5 minutes after end of surgery

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Principal Investigator: Yasser S Mostafa, MD, Fayoum University; Study Chair: Mohamed A Shawky, MD, Fayoum University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Nasal surgery; Emergence agitation
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Behavioral Symptoms; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Dyskinesias; Psychomotor Disorders; Delirium; Emergence Delirium; Psychomotor Agitation; Nose Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: R656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No