Emergence agitation in adults: risk factors in 2,000 patients.
Daihua Yu, Wei Chai, Xude Sun...
https://pubmed.ncbi.nlm.nih.gov/20526708Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06867302
Effectiveness of Single Bolus Versus Continuous Infusion of Dexmedetomidine in Mitigating Agitation in Adults Undergoing Nasal Surgery: a Prospective Randomized Trial
Led by Fayoum University Hospital · Updated on 2025-03-10
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of dexmedetomidine to reduce emergence agitation in obese adults undergoing nasal surgery. Emergence agitation is a serious condition that can occur when waking from general anesthesia, leading to risks like self-injury, aspiration, and other complications. This study compares a single bolus dose given before extubation with a continuous infusion to find the most effective way to reduce agitation. The trial is a prospective randomized study sponsored by Fayoum University Hospital and focuses on adults aged 18 to 50 years with a body mass index below 30 undergoing elective nasal surgery. Participants receive either a single dose of dexmedetomidine at 0.5 µg/kg in saline over 10 minutes starting 15 minutes before the end of surgery or a continuous infusion of dexmedetomidine at 0.5 µg/kg/hour during the operation without a loading dose. Standard anesthesia monitoring is used, including electrocardiogram, pulse oximetry, and non-invasive blood pressure. Anesthesia is maintained with isoflurane, and muscle relaxation is reversed before extubation. Patients are then transferred to the postanesthesia care unit (PACU) once awake, calm, and sedated. Various rescue drugs and supportive care are provided as needed. During the study, participants are closely monitored for heart rate, blood pressure, agitation level using the Richmond Agitation Sedation Scale five minutes after surgery, and other outcomes like extubation time, PACU time, analgesic use, and incidence of side effects. Follow-up occurs up to 24 hours after surgery to assess pain, nausea, vomiting, and surgical field quality. The total participation includes the surgery and post-operative care until discharge from PACU. Statistical analysis will compare the two dexmedetomidine dosing methods to determine their effects on emergence agitation and related outcomes.
CONDITIONS
Brief Title
Dexmedetomidine and Agitation After Nasal Surgery
Who Can Participate
Age: 18Years - 50Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologist (ASA) I or II
- Adults with body mass index (BMI) < 30 Kg/m2
- Underwent elective nasal surgery
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of the nasal surgery (intraoperative period)
Participants undergo nasal surgery and receive dexmedetomidine either as a single bolus dose 15 minutes before the end of surgery or as a continuous infusion throughout the surgery to prevent emergence agitation.
1 surgical procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 24 hours after surgery
Participants are monitored in the postanesthesia care unit (PACU) until they are awake, calm, and meet discharge criteria. Monitoring includes assessment for agitation, pain, vital signs, and adverse events for up to 24 hours after surgery.
Continuous monitoring during PACU stay and assessments up to 24 hours postoperatively
Trial Site Locations
Total: 1 location
1
Fayoum University Hospital
Al Fayyum, Faiyum Governorate, Egypt, 63514
Actively Recruiting
Loading map...
Research Team
Y
Yasser S Mostafa, MD
M
Mohamed A Shawky, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Emergence delirium: a nursing perspective.
Kim Hudek
https://pubmed.ncbi.nlm.nih.gov/19326585Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery.
Hyo-Jin Kim, Duk-Kyung Kim, Hyo-Yeol Kim...
https://pubmed.ncbi.nlm.nih.gov/25729495Emergence delirium in adults in the post-anaesthesia care unit.
C Lepousé, C A Lautner, L Liu...
https://pubmed.ncbi.nlm.nih.gov/16670111Meta-analysis of dexmedetomidine on emergence agitation and recovery profiles in children after sevoflurane anesthesia: different administration and different dosage.
Min Zhu, Haiyun Wang, Ai Zhu...
https://pubmed.ncbi.nlm.nih.gov/25874562