Pregabalin Stabilize Cardiovascular Response to Intubation

Effect of Laryngoscopy and Tracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456947
• Other study ID #: CWW-PRBL-2017
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2018
• Last updated: March 8, 2018
• Start date: January 1, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2018
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Laryngoscopy and Tracheal Intubation

Intervention

Drug:
• Pregabalin
the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Ramsay score	Ramsay score of 300mg pregabalin, 150mg pregabalin premedication versus	baseline Ramsay score before drug administration and Ramsay score before intubation
Secondary	Incidence of all clinical adverse events	The occurrence of dizziness, nausea, vomit and allergy	1hour after surgery