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Safety of Remifentanil Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303627
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : June 18, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Urinary Tract Problem
Intervention Drug: remifentanil
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ultiva,Remifentanil,Opioid,Analgesic Control
Hide Arm/Group Description Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery Control:Remifentanil stopped at the end of the surgery
Period Title: Overall Study
Started 21 21
Completed 21 20 [1]
Not Completed 0 1
Reason Not Completed
the failure while performing URS             0             1
[1]
One patient excluded from the study because of the failure while performing uretero-renoscopy
Arm/Group Title Ultiva,Remifentanil,Opioid,Analgesic Control Total
Hide Arm/Group Description Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery Control:Remifentanil stopped at the end of the surgery Total of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
20
 100.0%
41
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 41 participants
41  (13) 38  (12) 39  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
2
   9.5%
6
  30.0%
8
  19.5%
Male
19
  90.5%
14
  70.0%
33
  80.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Turkey Number Analyzed 21 participants 20 participants 41 participants
21 20 41
1.Primary Outcome
Title Smooth cLMA Removal Condition (Score 1)
Hide Description 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)
Time Frame At the end of the surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Group Control Group
Hide Arm/Group Description:
remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
Remifentanil stopped at the and of the surgery
Overall Number of Participants Analyzed 21 20
Measure Type: Number
Unit of Measure: percentage of participants
86 40
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil Group, Control Group
Comments The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of <0.05 was considered statistically significant.
Method Chi-squared
Comments [Not Specified]
Time Frame During the surgery
Adverse Event Reporting Description serious and/or other [non-serious] adverse events were not collected/assessed.
 
Arm/Group Title Remifentanil Group Control Group
Hide Arm/Group Description remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal Remifentanil stopped at the end of the surgery
All-Cause Mortality
Remifentanil Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Remifentanil Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Remifentanil Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
The limitation of our study is age and ASA status of the included patients’. The relatively older or ASA status III,IV population may interfere the effect-site concentration TCI of remifentanil
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Derya Özkan MD
Organization: Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital 1. Anesthesiology
Phone: 0903125962553
EMail: derya_z@yahoo.com
Layout table for additonal information
Responsible Party: derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01303627    
Other Study ID Numbers: DiskapiTRH
First Submitted: February 24, 2011
First Posted: February 25, 2011
Results First Submitted: January 30, 2012
Results First Posted: June 18, 2012
Last Update Posted: June 25, 2012