Effect of Laryngoscopy and Tracheal Intubation
Conditions
Brief summary
The purpose of the study is to evaluate whether Pregabalin is safe and effective in stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under general anesthesia.
Interventions
DRUGPregabalin
the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists(ASA) grade I and II scheduled for elective surgery
Exclusion criteria
* patient refusal. * patients with serious chronic kidney, liver, lungs, or cardiovascular diseases. * allergy to any of the study medications. * patients taking sedation or antihypertensive medications. * suspected difficult intubation or intubation time more than 22s. * pregnant or breastfeeding women. * BMI\>30.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| heart rate | heart rate 3 minutes after intubation | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the heart rate due to laryngoscopy and tracheal intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial blood pressure | baseline mean arterial blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the Mean arterial blood pressure due to laryngoscopy and tracheal intubation |
| systolic blood pressure | baseline systolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the systolic blood pressure due to laryngoscopy and tracheal intubation |
| diastolic blood pressure | baseline diastolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the diastolic blood pressure due to laryngoscopy and tracheal intubation |
| Ramsay score | baseline Ramsay score before drug administration and Ramsay score before intubation | Ramsay score of 300mg pregabalin, 150mg pregabalin premedication versus |
| Incidence of all clinical adverse events | 1hour after surgery | The occurrence of dizziness, nausea, vomit and allergy |
Outcome results
None listed