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CompletedNCT03456947Updated Mar 9, 2018

Pregabalin Stabilize Cardiovascular Response to Intubation

A Phase 4 interventional study of Pregabalin in Effect of Laryngoscopy and Tracheal Intubation, sponsored by Shanghai Zhongshan Hospital. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Effect of Laryngoscopy and Tracheal Intubation
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiologists(ASA) grade I and II scheduled for elective surgery

Exclusion criteria

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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

  • Experimental
    Pregabalin300mg group

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

    Drug: Pregabalin

Interventions

  • DrugPregabalin

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

05

What researchers measure

Primary outcomes

  1. heart rate

    effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the heart rate due to laryngoscopy and tracheal intubation

    Time frame: heart rate 3 minutes after intubation

Secondary outcomes

  1. 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

    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

  2. systolic blood pressure

    effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the systolic blood pressure due to laryngoscopy and tracheal intubation

    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

  3. diastolic blood pressure

    effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the diastolic blood pressure due to laryngoscopy and tracheal intubation

    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

  4. Ramsay score

    Ramsay score of 300mg pregabalin, 150mg pregabalin premedication versus

    Time frame: baseline Ramsay score before drug administration and Ramsay score before intubation

  5. Incidence of all clinical adverse events

    The occurrence of dizziness, nausea, vomit and allergy

    Time frame: 1hour after surgery

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Chen W, Huang H, Yang C, Hu X, Bao F, Jiang H. Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China. Clin Ther. 2019 Jan;41(1):68-77. doi: 10.1016/j.clinthera.2018.11.006. Epub 2018 Dec 13. PubMed 30553555 ↗
08

Registry details

Key details

Study ID
NCT03456947
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Jan 1, 2017
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Mar 9, 2018

Study contacts

Wei Chen
principal investigator · Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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