N/A
N=81
Intranasal Dexmedetomidine Premedication
Benign Neoplasm of Vocal Fold - Glottis
Bottom Line
View on ClinicalTrials.gov: NCT02108171 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Extubation Time After Intranasal Dexmedetomidine Premedication — 18.58; 17.16; 16.21; 14.74 min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexmedetomidine (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guangzhou First People's Hospital
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extubation Time After Intranasal Dexmedetomidine Premedication |
18.58; 17.16; 16.21; 14.74; 8.24; 7.87 | — |
| SECONDARY Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine |
6; 6; 4; 6; 4; 4 | — |
| SECONDARY Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine |
71.75; 72.2; 66.93; 71.53; 65.63; 72 | — |
| SECONDARY Number of Participants With Anxiety Score >2 |
25; 23; 39; 29 | — |
| SECONDARY Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine |
3; 3; 3; 3 | — |
| SECONDARY Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine |
120.8684; 116.8462; 120.5641; 126.875; 117.725; 122.6 | — |
| SECONDARY Number of Participants With Satisfaction Score <2 |
34; 25 | — |
| SECONDARY Perioperative Bradycardia Episodes |
2; 0; 1; 1; 3; 5 | — |
| SECONDARY Perioperative Tachycardia Episodes |
0; 0; 1; 8; 5; 11 | — |
| SECONDARY Perioperative Hypotension Episodes |
0; 2; 3; 4; 3; 4 | — |
| SECONDARY Perioperative Hypertonsion Episodes |
1; 0; 6; 0; 6; 5 | — |
Summary
Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.
Eligibility Criteria
Inclusion Criteria
- Surgery:The laryngoscope vocal polyp excision
- Aged 18 to 60 years old
- Body mass index (BMI) < 30 kg/m2
- American society of Anesthesiologist (ASA) I -II
Exclusion Criteria
- The investigator refused to participate
- Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
- With previous history of heart disease
- Pregnant women; no reliable contraceptive measures in postmenopausal women
- Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
- Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
- Asthma
- Sleep apnea syndrome
- Liver and kidney dysfunction
- Known to suffer from mental illness
- Long-term use of sedatives and analgesics in patients
Data sourced from ClinicalTrials.gov (NCT02108171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.