Trial Outcomes & Findings for Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena (NCT NCT00798018)

NCT ID: NCT00798018

Last Updated: 2009-12-18

Results Overview

visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 hours, 12 hours, 24 hours, 48 hours after extubation
• Results posted on: 2009-12-18

Participant Flow

The study started in November 2008 and finished in February 2009, in total 100 patients were enrolled and all of them finished this study.

Participant milestones

Measure	Air Alone Only air was injected into the cuff, as the routine practice	Normal Saline normal saline was used to inflate the cuff	Lidocaine 2% lidiocaine was used to inflate the cuff	Tetracaine 1% tetracaine was used to inflate the cuff
Overall Study STARTED	25	25	25	25
Overall Study COMPLETED	25	25	25	25
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena

Baseline characteristics by cohort

Measure	Air Alone n=25 Participants Only air was injected into the cuff, as the routine practice	Normal Saline n=25 Participants normal saline was used to inflate the cuff	Lidocaine n=25 Participants 2% lidiocaine was used to inflate the cuff	Tetracaine n=25 Participants 1% tetracaine was used to inflate the cuff	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	100 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	39 years STANDARD_DEVIATION 8 • n=5 Participants	44 years STANDARD_DEVIATION 9 • n=7 Participants	42 years STANDARD_DEVIATION 7 • n=5 Participants	41 years STANDARD_DEVIATION 10 • n=4 Participants	42 years STANDARD_DEVIATION 9 • n=21 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	100 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment China	25 participants n=5 Participants	25 participants n=7 Participants	25 participants n=5 Participants	25 participants n=4 Participants	100 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 hours, 12 hours, 24 hours, 48 hours after extubation

visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.

Outcome measures

Measure	Air Alone n=25 Participants Only air was injected into the cuff, as the routine practice	Normal Saline n=25 Participants normal saline was used to inflate the cuff	Lidocaine n=25 Participants 2% lidiocaine was used to inflate the cuff	Tetracaine n=25 Participants 1% tetracaine was used to inflate the cuff
Visual Analogue Scale(0-100mm) by the Subject. 6h	51 mm Standard Deviation 37	40 mm Standard Deviation 31	22 mm Standard Deviation 17	9 mm Standard Deviation 8
Visual Analogue Scale(0-100mm) by the Subject. 12h	50 mm Standard Deviation 33	38 mm Standard Deviation 19	25 mm Standard Deviation 15	13 mm Standard Deviation 7
Visual Analogue Scale(0-100mm) by the Subject. 24h	43 mm Standard Deviation 39	41 mm Standard Deviation 30	20 mm Standard Deviation 18	7 mm Standard Deviation 5
Visual Analogue Scale(0-100mm) by the Subject. 48h	45 mm Standard Deviation 36	43 mm Standard Deviation 25	23 mm Standard Deviation 19	9 mm Standard Deviation 4

Adverse Events

Air Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tetracaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Han Huang

Department of Anesthesiology, West China Second Hospital

Phone: 80-028-8550-3753

Email: huanghan1981@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place