Pregabalin Stabilize Cardiovascular Response to Intubation

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

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.

Study Overview

• Status: Completed
• Conditions: Effect of Laryngoscopy and Tracheal Intubation
• Intervention / Treatment: Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Wei Chen, Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: CWW-PRBL-2017

Drug and device information, study documents

• 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