Trial Outcomes & Findings for Safety of Remifentanil Infusion (NCT NCT01303627)

NCT ID: NCT01303627

Last Updated: 2012-06-25

Results Overview

cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 42 participants
• Primary outcome timeframe: At the end of the surgery
• Results posted on: 2012-06-25

Participant Flow

Participant milestones

Measure	Ultiva,Remifentanil,Opioid,Analgesic Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery	Control Control:Remifentanil stopped at the end of the surgery
Overall Study STARTED	21	21
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Ultiva,Remifentanil,Opioid,Analgesic Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery	Control Control:Remifentanil stopped at the end of the surgery
Overall Study the failure while performing URS	0	1

Baseline Characteristics

Safety of Remifentanil Infusion

Baseline characteristics by cohort

Measure	Ultiva,Remifentanil,Opioid,Analgesic n=21 Participants Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery	Control n=20 Participants Control:Remifentanil stopped at the end of the surgery	Total n=41 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
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	41 years STANDARD_DEVIATION 13 • n=5 Participants	38 years STANDARD_DEVIATION 12 • n=7 Participants	39 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment Turkey	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the surgery

cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)

Outcome measures

Measure	Remifentanil Group n=21 Participants remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal	Control Group n=20 Participants Remifentanil stopped at the and of the surgery
Smooth cLMA Removal Condition (Score 1)	86 percentage of participants	40 percentage of participants

Adverse Events

Remifentanil Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Derya Özkan MD

Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital 1. Anesthesiology

Phone: 0903125962553

Email: derya_z@yahoo.com

Results disclosure agreements

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