Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine

Drug Usage Clinical Trial

Official title:

Effect of Tracheal Lidocaine on Intubating Conditions During Propofol-remifentanil TCI Without Neuromuscular Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489683
• Other study ID #: AJIRB-MED-CT4-11-073
• Status: Completed
• Phase: N/A
• First received: December 7, 2011
• Last updated: July 13, 2012
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

When not using neuromuscular blocking agent, even at optimal dosage, target-controlled infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on the intubating conditions for tracheal intubation during anesthesia induction of propofol and remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.

Description:

Anesthesia was induced with propofol-remifentanil TCI with the effect-site concentration of 5μg/ml and 5ng/ml, respectively. After TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, following intubation was performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I, II patients undergoing general anesthesia for reduction of nasal bone fracture

Exclusion Criteria:

• bronchial asthma,

• COPD,

• hypertension,

• anticipated difficult airway

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Usage

Intervention

Drug:
• lidocaine
3 ml of 4% lidocaine was instilled to larynx and trachea
• normal saline
3 ml of normal saline was instilled to larynx and trachea before endotracheal intubation

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Bülow K, Nielsen TG, Lund J. The effect of topical lignocaine on intubating conditions after propofol-alfentanil induction. Acta Anaesthesiol Scand. 1996 Jul;40(6):752-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall acceptable conditions for tracheal intubation	Four minutes after start of propofol-remifentanil TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, and one minute later, intubation was performed in double-blinded fashion.	baseline from 5 min of TCI was maintained	Yes