Emergence AgitationNCT07880938
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
A study testing Dexmedetomidin and Esketamine in people with Emergence Agitation and Vocal Cord Polyps, run by The First Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emergence Agitation, Vocal Cord Polyps
- What is being tested?
- Dexmedetomidin and Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Dexmedetomidine Nasal Spray Combined With Esketamine on the Quality of Recovery in Patients Undergoing Suspension Laryngoscopy Surgery
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.
- Conditions
- Emergence Agitation, Vocal Cord Polyps
- Being tested
- Dexmedetomidin, Esketamine
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidinDrug
Dexmedetomidine will be administered intravenously before anesthesia induction in both groups.
EsketamineDrug
Esketamine will be administered intravenously before anesthesia induction only in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients receive dexmedetomidine before anesthesia induction. Receives: Drug: Dexmedetomidin |
| Intervention Grop | Experimental | Patients receive dexmedetomidine combined with esketamine before anesthesia induction. Receives: Drug: Dexmedetomidin; Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence agitation within 60 minutes after surgery
The incidence of emergence agitation evaluated by Ricker Sedation-Agitation Scale (RSAS) within 60 minutes after the end of surgery.
Measured: 60 minutes after the end of surgery
Secondary outcomes (3)
ncidence of cough during anesthesia induction
The incidence of cough events observed during anesthesia induction.
Measured: During anesthesia induction
Changes of mean arterial pressure during anesthesia induction
The variation of mean arterial pressure at multiple time points from baseline to 5 minutes after tracheal intubation.
Measured: From baseline to 5 minutes after tracheal intubation
Incidence of adverse hemodynamic events during induction
The occurrence of hypotension or hypertension events during anesthesia induction.
Measured: From baseline to 5 min after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups in 1:1 random allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880938
- Sponsor's protocol ID
- 2026-HS-0039
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No