Viewing Study NCT01185535



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Last Modification Date: 2024-10-26 @ 10:24 AM
Study NCT ID: NCT01185535
Status: UNKNOWN
Last Update Posted: 2010-08-20
First Post: 2010-07-26

Brief Title: Effects of Topical Anesthesia With Pressure Nebulized 2 Lidocaine During Awake Intubation
Sponsor: Sun Yat-sen University
Organization: Sun Yat-sen University

Study Overview

Official Title: Effects of Topical Anesthesia With Pressure Nebulized 2 Lidocaine During Awake Intubation
Status: UNKNOWN
Status Verified Date: 2010-04
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: As reported about 043 patients can not be intubated unevenly because of difficult airway and 30 of the total death of anesthesia due to failed intubation The difficult airway will disturb the clinical treatment and even threaten the patients life But the present methods for tracheal intubation during awake intubation can not provided ideal intubation condition In this study the investigators will perform topical anesthesia with the nebulized 2 lidocaine at 10Lmin oxygen flow rate and the observers assessment of alert and sedation OAAS scale was controlled to 3-4 points by intravenous midazolampropofol and remifentanil Tracheal intubation was performed after topical anesthesia The arterial pressure MAP heart rate HR and pulse oxygen saturation SpO2 were recorded and blood samples were taken to measure stress factor during intubation periodIntubation condition score was assessed and the complications like local anesthetic toxicity mucosa injury respiration depress were also recorded Patients were asked whether they could recall the events during intubation 24 hr after operation The investigators aim is to evaluate the effect of topical anesthesia with lidocaine nebulized by 10Lmin oxygen flow rate during awake tracheal intubation
Detailed Description: 90 adult patients for elective surgery under general anesthesia aged 18-60 years old Mallampti Ⅰ-Ⅱ class were randomly allocated to receive topical anesthesia with pressure nebulized 2 lidocaine for glottis either two times or three times or four timeseach group n30 Before topical anesthesia the observers assessment of alert and sedation OAAS scale was controlled to 3-4 points by intravenous midazolam 003mgkg propofol 2mgkgh and remifentanil 005μgkgmin Ten minutes after sedation topical anesthesia was performed with the nebulized 2 lidocaine at 10Lmin oxygen flow rate meantime patients were told to breathe deeply Tracheal intubation was performed after topical anesthesia The arterial pressure MAP heart rate HR and pulse oxygen saturation SpO2 were recorded and blood samples were taken to measure the serum cortisol and insulin concentration during intubation period Intubation condition score was assessed and the complications like local anesthetic toxicity mucosa injury respiration depress were also recorded Patients were asked whether they could recall the events during intubation 24 hr after operation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None