The Effect of Dexmedetomidine Versus Lidocaine on Emergence Agitation.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Lidocaine; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khaled E Tolba, MBBCH; Phone Number: 01002568304; Email: ket11@fayoum.edu.eg
• Study Contact Backup: Name: Mohamed A Hamed, MD; Phone Number: 01010509736

Study Locations

• Egypt
  • Al Fayyum, Egypt, 63511
    • FayoumU
    • Contact: Khaled E Tolba, MBBCH; Phone Number: 01002568304; Email: ket11@fayoum.edu.eg
    • Contact: Mohamed A Hamed, MD; Phone Number: 01010509736
    • Principal Investigator: Khaled E Tolba, MBBCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group L; Active 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	Drug: Lidocaine; 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
Active Comparator: Group D; Active 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	Drug: Dexmedetomidine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of emergence agitation (EA) .	Incidence of emergence agitation (EA) as measured by Richmond Agitation Sedation Scale (RASS) .	Immediate after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate (beats per minute )	heart rate (beats per minute ) was measured using standard ECG monitoring	baseline ( preoperative )
heart rate (beats per minute )	heart rate (beats per minute ) was measured using standard ECG monitoring	after 30 minutes ( intraoperative)
heart rate (beats per minute)	heart rate (beats per minute ) was measured using standard ECG monitoring	after 60 minutes ( intraoperative )
heart rate (beats per minute)	heart rate (beats per minute ) was measured using standard ECG monitoring	0 hour postoperative
heart rate (beats per minute)	heart rate (beats per minute ) was measured using standard ECG monitoring	1 hour postoperative
heart rate (beats per minute)	heart rate (beats per minute ) was measured using standard ECG monitoring	3 hours postoperative
heart rate (beats per minute)	heart rate (beats per minute ) was measured using standard ECG monitoring	6 hours postoperative
heart rate (beats per minute)	heart rate (beats per minute ) was measured using standard ECG monitoring	12 hours postoperative
heart rate (beats per minute)	heart rate (beats per minute ) was measured using standard ECG monitoring	24 hours postoperative
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	baseline ( preoperative )
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	after 30 minutes ( intraoperative )
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	after 60 minutes ( intraoperative )
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	0 hour post operative
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	1 hour post operative
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	3 hour post operative
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	6 hour post operative
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	12 hour post operative
Mean arterial blood pressure (mmHg)	MAP ( mmHg) was measured using standard non-invasive blood pressure monitoring .	24 hour post operative
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	baseline ( preoperative )
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	after 30 minutes ( intraoperative )
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	after 60 minutes ( intraoperative)
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	0 hour post operative
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	1 hour post operative
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	3 hour post operative
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	6 hour post operative
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	12 hour post operative
Peripheral oxygen saturation (SpO2, %)	Peripheral oxygen saturation (SpO2, %) was measured using pulse oximetry	24 hour post operative
Postoperative pain score	Postoperative pain was assessed using the Numeric rating scale (NRS) , ranging from 0 ( no pain ) to 10 ( worst imaginable pain )	0, 1 h(hour), 3h, 6h, 12h, 24h postoperatively
Incidence of adverse events	Incidence of adverse events including postoperative nausea&vomiting , allergy , bradycardia (HR<50) , hypotension (MAP decreases by >20%) , desaturation ( SpO2<92%)	first 24 hours postoperative

Collaborators and Investigators

• Sponsor: Fayoum University
• Investigators: Principal Investigator: Khaled E Tolba, MBBCH

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 21, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Intravenous lidocaine; Endoscopic sinus surgery; Emergence agitation; Intravenous dexmedetomidine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine; Dexmedetomidine
• Other Study ID Numbers: M786

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