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Pregabalin Stabilize Cardiovascular Response to Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456947
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Effect of Laryngoscopy and Tracheal Intubation Drug: Pregabalin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Research of Pregabalin Stabilize Cardiovascular Response to Laryngoscopy and Tracheal Intubation of Patients Under General Anesthesia
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
No Intervention: control group
the patients receive routine preoperative preparation without having Pregabalin
Experimental: Pregabalin150mg group
the patients receive 150mg pregabalin 60 minutes prior to the surgery
 Drug: Pregabalin
the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery
Experimental: Pregabalin300mg group
the patients receive 300mg pregabalin 60 minutes prior to the surgery
 Drug: Pregabalin
the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery


Outcome Measures
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Primary Outcome Measures :
  1. heart rate [ Time Frame: 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 Outcome Measures :
  1. Mean arterial blood pressure [ Time Frame: 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

  2. systolic blood pressure [ Time Frame: 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

  3. diastolic blood pressure [ Time Frame: 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

  4. Ramsay score [ Time Frame: baseline Ramsay score before drug administration and Ramsay score before intubation ]
    Ramsay score of 300mg pregabalin, 150mg pregabalin premedication versus

  5. Incidence of all clinical adverse events [ Time Frame: 1hour after surgery ]
    The occurrence of dizziness, nausea, vomit and allergy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456947


Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Wei Chen Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03456947    
Other Study ID Numbers: CWW-PRBL-2017
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs