Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04771026 |
| Other study ID # |
USM/JEPeM/19120934 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
September 2023 |
| Source |
Universiti Sains Malaysia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to study the effectiveness of preoperatively nebulized dexamethasone in
reducing the incidence and severity of Post Operative Sore Throat, POST in patients
undergoing surgery under general anesthesia using the Ambu® AuraGainTM SGA device, with
secondary aims of determining the effectiveness of dexamethasone in reducing post-operative
cough severity and hoarseness of voice
Description:
The role of dexamethasone in reducing the incidence and severity of postoperative sore throat
(POST) with ETT use is established in few studies. Some of the studies had done were found to
have result on pertaining to efficacy of steroids in reducing incidences of POST in usage of
SGA device, hence we decided to undertake this double-blinded, randomized study in patients
undergoing general anaesthesia using the Ambu® AuraGainTM SGA device.
Dexamethasone which is 26.6 and 6.6 more potent than cortisol and prednisolone, acts via
anti-inflammatory effects; inhibiting and reducing the release of inflammatory mediators.
Hence this study aims to study the effectiveness of preoperative nebulized dexamethasone in
reducing the incidence and severity of POST to improve patient satisfaction following general
anaesthesia,and reduce morbidity.
OBJECTIVES
General:
To determine the effectiveness of preoperatively nebulized dexamethasone in reducing the
incidence of post-operative sore throat following Ambu® AuraGainTM SGA device use.
Specific:
1. To compare the incidence of post-operative sore throat (POST) with pre-operatively
nebulized dexamethasone following insertion of Ambu® AuraGainTM SGA device at 30 minutes
and 24 hours post operatively.
2. To compare the severity of POST with pre-operatively nebulized dexamethasone using a
visual analogue scale (VAS) following insertion of Ambu® AuraGainTM SGA device at 30
minutes and 24 hours post-operatively.
3. To compare the incidence and severity of cough with pre-operatively nebulized
dexamethasone using a 4-point scale grading at 30 minutes and 24 hours post-operatively
following the insertion of Ambu® AuraGainTM SGA device.
4. To compare the incidence and severity of hoarseness of voice with pre-operatively
nebulized dexamethasone using a 4-point scale grading at 30 minutes and 24 hours
post-operatively following the insertion of Ambu® AuraGainTM SGA device.
HYPOTHESIS
Null hypothesis H0:
There is no difference in terms of efficacy of pre-operatively nebulised dexamethasone in
reducing the incidence and severity of POST Sore throat, cough and hoarseness will be graded
as per Tazeh-Kand et al's study
Alternative hypothesis H1:
Pre-operatively nebulised dexamethasone is effective in reducing the incidence and severity
of POST Sore throat, cough and hoarseness will be graded as per Tazeh-Kand et al's study
RESEARCH DESIGN The proposed study design is a single-centre, randomized, double-blind,
controlled, parallel-group interventional study conducted in Kelantan, Malaysia.
Patients will be randomized (using a block randomization software) to 2 study arms (1:1
ratio), into Groups C and D whereby:
Group C: Control group, patients receiving usual standard of care in practice of SGA device
(including analgesics), without receiving any active drug.
Group D: Patients receiving nebulised dexamethasone 8mg (2ml) with 3mls of normal saline 0.9%
30 minutes prior to induction of anaesthesia in the pre-operative receiving room via a
wall-mounted oxygen source at 15L/minute.
After randomization, each patient will stay in their assigned treatment arm for the duration
of the study.
This will be a double-blinded randomized controlled study, carried out by a single operator
and assessor. Both operator/ assessor and patient will be blinded.
STUDY AREA Operating theatres in Hospital Universiti Sains Malaysia, HUSM, Kubang Kerian.
INTERVENTIONS Group C: Control group, patients receiving usual standard of care in practice
of SGA device (including analgesics), without receiving any active drug.
Group D: Patients receiving nebulised dexamethasone 8mg (2ml) with 3mls of normal saline 0.9%
30 minutes prior to induction of anaesthesia in the pre-operative receiving room via a
wall-mounted oxygen source at 15L/minute.
SAMPLE SIZE ESTIMATION The sample size was estimated using the PS Software version 3.1.2
(Dupont and Plummer 1997) based on comparing 2 proportions for incidence of sore throat, And
G*Power version 3.1.9.4 (Erdfelder, Faul, & Buchner, 1996) based on a 3 point scale for
determining the severity of sore throat, cough and hoarseness of voice.
Where:
- Alpha: 0.05
- Power: 80%
Based on the parameters in the study by Tazeh-Kand NF, Eslami B, Mohammadian K. Inhaled
fluticasone propionate reduces postoperative sore throat, cough, and hoarseness. Anesth
Analg. 2010 Oct;111(4):895-8 (23).
The largest sample size generated was 128 (for 64 patients in each arm) for incidence of
cough 1 hour post-operatively to detect a 30% difference in prevalence of cough between 2
study groups with a alpha value of 0.05 and power of 80%.
DATA COLLECTION METHOD After written consent pre-operatively, patients will be randomized as
2 groups
- Group C, and Group D. Group C: Patients receiving normal conduct of anaesthesia Group D:
Patients receiving dexamethasone 8mg (2ml) with 3mls of normal saline 0.9%.
Patients will receive a sealed, opaque envelope containing a code with either N or D
according to the randomization software pre-operatively, which will be opened by an
anesthesiologist or nurse not involved in the study. The anesthesiologist or nurse opening
the envelope will be told to withhold this information from the operator/investigator and
patient. If the envelope contains the letter D, the said nurse/ anesthesiologist will be told
to prepare and administer the nebulised drug as described, also without the knowledge of the
operator/investigator. The operator/investigator will have no contact with the patient once
the envelope is opened, and will remain away from the preoperative receiving room for 30
minutes from the arrival of patient.
Patients in group D will receive a total of 5mls of nebulized drug 30 minutes prior to
induction of anaesthesia in the pre-operative receiving room via a wall-mounted oxygen source
at 15L/minute.
After nebulisation for 30 minutes in the pre-operative receiving area, patients will be
brought to the respective operating theatre. Monitoring according to standards will be
applied - Non-invasive blood pressure, ECG, oxygen saturation, and capnography.
A humidified gas exchanger will be used for all patients.
Conduct of anesthesia will be as follows:
- Patients will not be premedicated
- Patients will be pre-oxygenated with 100% oxygen for 3-5 minutes or until an end-tidal
oxygen fraction of 85 is achieved
- Intravenous induction with IV Fentanyl 1-2 mcg/kg, IV Propofol 1-3mg/kg, with no use of
neuromuscular blockade of IV Dexamethasone.
- The insertion of a fully deflated SGA AMBU AURAGAIN® lubricated with Lignocaine 2% on
the posterior aspect using the appropriate size according to patients' weight once there
is loss of eyelash reflex by the operator using a standardized technique. The cuff will
then be inflated with appropriate amount of air according to LMA size
- Cuff pressure will be measured immediately once the airway is secured, and subsequently
measured hourly using a handheld pressure gauge. Cuff pressure of not more than 60 cmH20
will be maintained
- Anaesthesia will be maintained using Sevoflurane, titrated to a Minimum Alveolar
Concentration (MAC) of 0.9-1.0 in 50/50 oxygen/air mixture with SIMV (Pressure or volume
control) mode
- At the end of anaesthesia, the oral airway will be suctioned once gently and 100% oxygen
will be administered until the SGA removed without deflation once regular, spontaneous
ventilation has returned with opening of eyes to calling of name
Patients will be transferred to the recovery area where all patient will receive supplemental
oxygen via face mask at 5L/minute until discharged from the post-operative recovery unit.
The 4 point questionnaire on POST will be applied at 30 minutes to 1 hour and 24 hours
post-operatively in the ward by the same operator. If the patient is discharged prior to the
24 hour interview, they will be followed up via phone.
Scoring System for Sore Throat, Cough and Hoarseness, from Tazeh-kand et al:
