Clinical trial

The Effectiveness of Preemptive Nebulized Dexamethasone in Reducing Post- Operative Sore Throat Following the Use of AMBU® AURAGAINTM Device: A Double Blind, Randomised Clinical Trial

Name
USM/JEPeM/19120934
Description
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
Trial arms
Trial start
2020-12-01
Estimated PCD
2021-12-31
Trial end
2021-12-31
Status
Completed
Treatment
Dexamethasone
Pre-operatively nebuliser dexamethasone 8mg prior to induction of anesthesia
Arms:
Dexamethasone
Other names:
Decan
Size
140
Primary endpoint
Incidence of POST up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone
up to 24 hours post-operatively
Eligibility criteria
Inclusion Criteria: * Between the ages of 18-70 years * American Society of Anaesthesiology (ASA) physical status of 1 and 2 * Patients undergoing elective procedures under general anaesthesia between the data collection period suitable for SGA device Exclusion Criteria: * Pre-existing sore throat/hoarseness on pre-operative assessment * Patients with history of postoperative nausea or vomiting * Recent (2 weeks) upper or lower respiratory tract infection * Known hypersensitivity to dexamethasone or on regular steroids * Uncontrolled diabetes of capillary blood sugar more than 10mmol/l on pre-operative assessment * Morbidly obese with BMI \> 40 kg/m2 * Procedure exceeding 3 hours duration * Procedure requiring prone or Trendelenburg position or manipulation of head post-induction * Oral and neck surgeries * Pregnant patients * Patients with cognitive disabilities * Patients requiring nasogastric tube or nasal temperature probe insertion * Patient refusal
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

1 product

4 indications

Indication
Sore Throat
Indication
Dysphonia
Indication
Dexamethasone