Pregabalin Stabilize Cardiovascular Response to Intubation

NCT03456947 | Completed Phase 4

• 1 other identifier: CWW-PRBL-2017
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Effect of Laryngoscopy and Tracheal Intubation

Outcome Measures

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

  heart rate 3 minutes after intubation

Secondary Outcomes (5)

• Mean arterial blood pressure

  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

  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

  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

  baseline Ramsay score before drug administration and Ramsay score before intubation

• Incidence of all clinical adverse events

  1hour after surgery

Study Arms (3)

control group

NO INTERVENTION

the patients receive routine preoperative preparation without having Pregabalin

Pregabalin150mg group

EXPERIMENTAL

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

Drug: Pregabalin

Pregabalin300mg group

EXPERIMENTAL

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

Drug: Pregabalin

Interventions

Pregabalin DRUG

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

Pregabalin150mg group; Pregabalin300mg group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (1)

• 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.

  PMID: 30553555 DERIVED

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Wei Chen

  Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 7, 2018
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03