Emergence Agitation, Vocal Cord Polyps
Conditions
Brief summary
This is a single-center, prospective, single-blinded, randomized controlled trial conducted at The First Hospital of Jilin University. A total of 134 adult patients aged 18-65 years with ASA Ⅰ-Ⅲ undergoing elective laryngoscopic surgery for vocal cord polyps will be enrolled. Subjects will be randomly assigned into two groups. The control group receives intranasal dexmedetomidine plus intravenous normal saline before anesthesia induction. The combination group receives the same dose of intranasal dexmedetomidine plus intravenous esketamine before induction. The primary objective is to compare the incidence of emergence agitation within 60 minutes after extubation. Secondary outcomes include hemodynamic changes, adverse events, recovery time, PACU stay, postoperative sore throat pain and quality of recovery at 24 hours. Standardized anesthesia induction and maintenance will be applied for all patients. The study aims to explore whether the combination of intranasal dexmedetomidine and esketamine improves recovery quality in patients undergoing suspension laryngoscopy.
Interventions
DRUGDexmedetomidin
Dexmedetomidine will be administered intravenously before anesthesia induction in both groups.
DRUGEsketamine
Esketamine will be administered intravenously before anesthesia induction only in the intervention group.
Sponsors
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants are blinded to group assignment. Anesthesiologists are not blinded.
Intervention model description
Two parallel groups in 1:1 random allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Aged 18-65 years, male or female. 2. ASA physical status Ⅰ or Ⅱ. 3. Scheduled for elective surgery under general anesthesia with tracheal intubation. 4\. Expected operation duration 30-180 minutes. 5. Able to understand the study content and sign written informed consent voluntarily.
Exclusion criteria
* 1\. Preoperative cognitive dysfunction or psychiatric disorders. 2. Known allergy to dexmedetomidine or esketamine. 3. Severe cardiac, respiratory, hepatic or renal insufficiency. 4. Predicted difficult airway. 5. Drug abuse or long-term use of sedatives. 6. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence agitation within 60 minutes after surgery | 60 minutes after the end of surgery | The incidence of emergence agitation evaluated by Ricker Sedation-Agitation Scale (RSAS) within 60 minutes after the end of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ncidence of cough during anesthesia induction | During anesthesia induction | The incidence of cough events observed during anesthesia induction. |
| Changes of mean arterial pressure during anesthesia induction | From baseline to 5 minutes after tracheal intubation | The variation of mean arterial pressure at multiple time points from baseline to 5 minutes after tracheal intubation. |
| Incidence of adverse hemodynamic events during induction | From baseline to 5 min after intubation | The occurrence of hypotension or hypertension events during anesthesia induction. |
Countries
China
Contacts
CONTACTlei zhou, MMed
Outcome results
None listed