Trial Outcomes & Findings for Post Operative Sore Throat and Dexamethasone (NCT NCT01052038)
NCT ID: NCT01052038
Last Updated: 2012-05-02
Results Overview
The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
24 hours
Results posted on
2012-05-02
Participant Flow
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.
No subjects were lost or excluded after consent was signed and prior to allocation.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
|
Overall Study
Protocol Violation
|
2
|
3
|
3
|
Baseline Characteristics
Post Operative Sore Throat and Dexamethasone
Baseline characteristics by cohort
| Measure |
Group 1 Placebo
n=40 Participants
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
|
Group 2: Dexamethasone 0.05mg/kg
n=40 Participants
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
|
Group 3:Dexamethasone 0.1mg/kg
n=40 Participants
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=39 Participants
|
40 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
120 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age Continuous
|
36 years
STANDARD_DEVIATION 11 • n=39 Participants
|
36 years
STANDARD_DEVIATION 7 • n=41 Participants
|
39 years
STANDARD_DEVIATION 11 • n=35 Participants
|
37 years
STANDARD_DEVIATION 9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=39 Participants
|
40 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
120 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=39 Participants
|
40 participants
n=41 Participants
|
40 participants
n=35 Participants
|
120 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.
Outcome measures
| Measure |
Group 2: Dexamethasone 0.05mg/kg
n=40 Participants
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
|
Group 3:Dexamethasone 0.1mg/kg
n=40 Participants
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
|
Group 1 Placebo
n=40 Participants
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
|
|---|---|---|---|
|
Subjects Assessment of Sore Throat Pain at 24 Hours
|
4 units on a scale (1 to 5)
Interval 3.0 to 5.0
|
5 units on a scale (1 to 5)
Interval 4.0 to 5.0
|
4 units on a scale (1 to 5)
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 24 hoursThe quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery
Outcome measures
| Measure |
Group 2: Dexamethasone 0.05mg/kg
n=40 Participants
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
|
Group 3:Dexamethasone 0.1mg/kg
n=40 Participants
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
|
Group 1 Placebo
n=40 Participants
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
|
|---|---|---|---|
|
Quality of Recovery at 24 Hours
|
179 units on a scale (30 to 200) higher scod
Interval 175.0 to 185.0
|
193 units on a scale (30 to 200) higher scod
Interval 192.0 to 195.0
|
171 units on a scale (30 to 200) higher scod
Interval 160.0 to 182.0
|
SECONDARY outcome
Timeframe: 3 hours.Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.
Outcome measures
| Measure |
Group 2: Dexamethasone 0.05mg/kg
n=40 Participants
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
|
Group 3:Dexamethasone 0.1mg/kg
n=40 Participants
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
|
Group 1 Placebo
n=40 Participants
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
|
|---|---|---|---|
|
Number of Subjects With Sore Throat at 3 Hours Post Surgery.
|
17 participants
|
10 participants
|
24 participants
|
SECONDARY outcome
Timeframe: 24 hoursThe cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine.
Outcome measures
| Measure |
Group 2: Dexamethasone 0.05mg/kg
n=40 Participants
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
|
Group 3:Dexamethasone 0.1mg/kg
n=40 Participants
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
|
Group 1 Placebo
n=40 Participants
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
|
|---|---|---|---|
|
Opioid Consumption at 24 Hours
|
20 mg of oral morphine equivalents
Interval 10.0 to 32.5
|
10 mg of oral morphine equivalents
Interval 10.0 to 20.0
|
20 mg of oral morphine equivalents
Interval 20.0 to 30.0
|
SECONDARY outcome
Timeframe: 24 hoursSelf assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview.
Outcome measures
| Measure |
Group 2: Dexamethasone 0.05mg/kg
n=40 Participants
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
|
Group 3:Dexamethasone 0.1mg/kg
n=40 Participants
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
|
Group 1 Placebo
n=40 Participants
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
|
|---|---|---|---|
|
Hoarseness at 24 Hours
No hoarseness
|
11 participants
|
18 participants
|
5 participants
|
|
Hoarseness at 24 Hours
No hoarseness at interview but present during 24h
|
6 participants
|
8 participants
|
10 participants
|
|
Hoarseness at 24 Hours
Hoarseness at interview noted by patient
|
11 participants
|
6 participants
|
15 participants
|
|
Hoarseness at 24 Hours
Hoarseness easily noted by interviewer
|
6 participants
|
4 participants
|
6 participants
|
Adverse Events
Group 1 Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Group 2: Dexamethasone 0.05mg/kg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Group 3:Dexamethasone 0.1mg/kg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Placebo
n=40 participants at risk
Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
|
Group 2: Dexamethasone 0.05mg/kg
n=40 participants at risk
Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
|
Group 3:Dexamethasone 0.1mg/kg
n=40 participants at risk
Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
|
|---|---|---|---|
|
Surgical and medical procedures
Sore throat
|
62.5%
25/40 • Number of events 25 • Adverse events were collected for 24 hours following surgery
|
47.5%
19/40 • Number of events 19 • Adverse events were collected for 24 hours following surgery
|
45.0%
18/40 • Number of events 18 • Adverse events were collected for 24 hours following surgery
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
50.0%
20/40 • Number of events 20 • Adverse events were collected for 24 hours following surgery
|
7.5%
3/40 • Number of events 3 • Adverse events were collected for 24 hours following surgery
|
15.0%
6/40 • Number of events 6 • Adverse events were collected for 24 hours following surgery
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
25.0%
10/40 • Number of events 10 • Adverse events were collected for 24 hours following surgery
|
20.0%
8/40 • Number of events 8 • Adverse events were collected for 24 hours following surgery
|
15.0%
6/40 • Number of events 6 • Adverse events were collected for 24 hours following surgery
|
Additional Information
Dr. Robert J. McCarthy
Northwestern University Feinberg School of Medicine
Phone: 312-926-9015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place