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Post Operative Sore Throat and Dexamethasone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01052038
First received: January 19, 2010
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
Results First Received: October 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Sore Throat
Pain
Interventions: Drug: Placebo administration
Drug: Dexamethasone 0.05mg/kr administration
Drug: Dexamethasone 0.1mg/kg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
ASA physical status I and II females undergoing outpatient gynaecological laparoscopy. Patients with a history of recent respiratory tract infection (<1 month), current use of an opioid analgesic or corticosteroid, pregnancy, or anticipated difficult airways were not enrolled. Subjects were enrolled between January 2010 thru September 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No subjects were lost or excluded after consent was signed and prior to allocation.

Reporting Groups
  Description
Group 1 Placebo Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Participant Flow:   Overall Study
    Group 1 Placebo     Group 2: Dexamethasone 0.05mg/kg     Group 3:Dexamethasone 0.1mg/kg  
STARTED     40     40     40  
COMPLETED     36     34     36  
NOT COMPLETED     4     6     4  
Lost to Follow-up                 2                 3                 1  
Protocol Violation                 2                 3                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Group 1 Placebo Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
Total Total of all reporting groups

Baseline Measures
    Group 1 Placebo     Group 2: Dexamethasone 0.05mg/kg     Group 3:Dexamethasone 0.1mg/kg     Total  
Number of Participants  
[units: participants]
 		  40     40     40     120  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     40     40     40     120  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  36  ± 11     36  ± 7     39  ± 11     37  ± 9  
Gender  
[units: participants]
 		       
Female     40     40     40     120  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     40     40     40     120  



  Outcome Measures
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1.  Primary:   Subjects Assessment of Sore Throat Pain at 24 Hours   [ Time Frame: 24 hours ]
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2.  Secondary:   Quality of Recovery at 24 Hours   [ Time Frame: 24 hours ]
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3.  Secondary:   Number of Subjects With Sore Throat at 3 Hours Post Surgery.   [ Time Frame: 3 hours. ]
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4.  Secondary:   Opioid Consumption at 24 Hours   [ Time Frame: 24 hours ]
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5.  Secondary:   Hoarseness at 24 Hours   [ Time Frame: 24 hours ]
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  Serious Adverse Events
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Time Frame Adverse events were collected for 24 hours following surgery
Additional Description No text entered.

Reporting Groups
  Description
Group 1 Placebo Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
Group 2: Dexamethasone 0.05mg/kg Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
Group 3:Dexamethasone 0.1mg/kg Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Serious Adverse Events
    Group 1 Placebo     Group 2: Dexamethasone 0.05mg/kg     Group 3:Dexamethasone 0.1mg/kg  
Total, serious adverse events        
# participants affected / at risk     0/40 (0.00%)     0/40 (0.00%)     0/40 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was limited to 2 doses of dexamethasone and was underpowered to assess side effects such as hyperglycemia or delayed wound healing. Study was limited to a single type of surgery and results may differ in different types of surgery.  


Results Point of Contact:  
Name/Title: Dr. Robert J. McCarthy
Organization: Northwestern University Feinberg School of Medicine
phone: 312-926-9015
e-mail: r-mccarthy@northwestern.edu


Publications of Results:


Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01052038     History of Changes
Other Study ID Numbers: STU00018901
Study First Received: January 19, 2010
Results First Received: October 31, 2011
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board