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Completed

NCT Number: NCT03456947

Pregabalin Stabilize Cardiovascular Response to Intubation

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.

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Key information

Conditions

Effect of Laryngoscopy and Tracheal Intubation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin

Drug

the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2018
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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