Pregabalin Stabilize Cardiovascular Response to Intubation

NCT ID: NCT03456947

Last Updated: 2018-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-06-30

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.

Detailed Description

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Conditions

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Effect of Laryngoscopy and Tracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group

the patients receive routine preoperative preparation without having Pregabalin

Group Type NO_INTERVENTION

No interventions assigned to this group

Pregabalin150mg group

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

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

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

Pregabalin300mg group

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

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

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

Interventions

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Pregabalin

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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Chen

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai

References

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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.

Reference Type DERIVED
PMID: 30553555 (View on PubMed)

Other Identifiers

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CWW-PRBL-2017

Identifier Type: -

Identifier Source: org_study_id

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