Pregabalin Stabilize Cardiovascular Response to Intubation

Study Overview
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Brief Summary
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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.

Official Title
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Research of Pregabalin Stabilize Cardiovascular Response to Laryngoscopy and Tracheal Intubation of Patients Under General Anesthesia

Conditions
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Effect of Laryngoscopy and Tracheal Intubation

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>the patients receive routine preoperative preparation without having Pregabalin | |
| Experimental: Pregabalin150mg group<br>the patients receive 150mg pregabalin 60 minutes prior to the surgery | Drug: Pregabalin<br>* the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery<br>|
| Experimental: Pregabalin300mg group<br>the patients receive 300mg pregabalin 60 minutes prior to the surgery | Drug: Pregabalin<br>* the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the heart rate due to laryngoscopy and tracheal intubation | heart rate 3 minutes after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the Mean arterial blood pressure due to laryngoscopy and tracheal intubation | 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 | 
| systolic blood pressure | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the systolic blood pressure due to laryngoscopy and tracheal intubation | 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 | 
| diastolic blood pressure | effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the diastolic blood pressure due to laryngoscopy and tracheal intubation | 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 | 
| Ramsay score | Ramsay score of 300mg pregabalin, 150mg pregabalin premedication versus | baseline Ramsay score before drug administration and Ramsay score before intubation | 
| Incidence of all clinical adverse events | The occurrence of dizziness, nausea, vomit and allergy | 1hour after surgery |