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Effect of Ketamine+Propofol vs Remifentanyl+Propofol on Laryngeal Mask Insertion Conditions

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ClinicalTrials.gov Identifier: NCT02583217
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
CIGDEM YILDIRIM GUCLU, Ankara University

Tracking Information
First Submitted Date September 18, 2015
First Posted Date October 22, 2015
Last Update Posted Date May 8, 2017
Study Start Date April 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2015)
High laryngeal mask insertion scores [ Time Frame: 3 minutes ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 20, 2015)
  • Hypotension [ Time Frame: 10 minutes ]
  • Hypertension [ Time Frame: 10 minutes ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Ketamine+Propofol vs Remifentanyl+Propofol on Laryngeal Mask Insertion Conditions
Official Title Effect of Ketamine+Propofol vs Remifentanyl+Propofol on Laryngeal Mask Insertion Conditions
Brief Summary Laryngeal mask airway is a common tool for airway management during anesthesia in many surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to compare the insertion conditions of laryngeal mask by using ketamine+propofol versus remifentanil + propofol.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Surgery performed with laryngeal mask as airway tool in gynecologic clinic
Condition Surgery
Intervention
  • Drug: Ketamine
    To compare ketamine+propofol versus remifentanyl+propofol to maintain good laryngeal mask insertion conditions
    Other Name: Remifentanyl
  • Drug: remifentanyl
  • Drug: propofol
  • Device: laryngeal mask
Study Groups/Cohorts
  • Ketamine
    Ketamine+propofol
    Interventions:
    • Drug: Ketamine
    • Drug: propofol
    • Device: laryngeal mask
  • Remifentanyl
    Remifentanyl+propofol
    Interventions:
    • Drug: remifentanyl
    • Drug: propofol
    • Device: laryngeal mask
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 20, 2015)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Surgery requires laryngeal mask

Exclusion Criteria:

  • Patient refusal, abdominal surgery required muscle relaxant, any allergy to ketamine or remifentanyl
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT02583217
Other Study ID Numbers ANK-42476
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CIGDEM YILDIRIM GUCLU, Ankara University
Study Sponsor Ankara University
Collaborators Not Provided
Investigators
Principal Investigator: CIGDEM YILDIRIM GUCLU, MD Ankara University
PRS Account Ankara University
Verification Date January 2016