Dexmedetomidine and Agitation After Nasal Surgery

NCT ID: NCT06867302

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-10-01

Brief 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.

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.

Conditions

Nasal Disease; Agitation, Emergence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bolus group

single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

An infusion given all through intraoperative time

Infusion group

Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time

Group Type: EXPERIMENTAL

Dexmedetomidine Injection [Precedex]

Intervention Type: DRUG

Single dose given 15 minutes before end of surgery

Interventions

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

An infusion given all through intraoperative time

Intervention Type: DRUG

Dexmedetomidine Injection [Precedex]

Single dose given 15 minutes before end of surgery

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine infusion; Dexmedetomidine bolus

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fayoum University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasser S Mostafa, MD

Lecturer of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasser S Mostafa, MD

Role: PRINCIPAL_INVESTIGATOR

Fayoum University

Mohamed A Shawky, MD

Role: STUDY_CHAIR

Fayoum University

Locations

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yasser S Mostafa, MD

Role: CONTACT

ysm03@fayoum.edu.eg

01010509735 ext. +2

Mohamed A Shawky, MD

Role: CONTACT

mas14@fayoum.edu.eg

0 109 525 4547 ext. +2

Facility Contacts

Yasser S Mostafa, MD.

Role: primary

ysm03@fayoum.edu.eg

01010509735 ext. +2

Mohamed A Shawky, MD

Role: backup

mas14@fayoum.edu.eg

01095254547 ext. +2

References

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.

Reference Type: BACKGROUND

PMID: 20526708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19326585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25729495 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16670111 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25874562 (View on PubMed)

Other Identifiers

R656

Identifier Type: -

Identifier Source: org_study_id