Anesthesia Intubation Complication, Tracheal Disease
Conditions
Keywords
Sore throat, Hoarseness, Intubation, Thyroidectomy, Ketorolac, Dexamethasone
Brief summary
Sore throat is one of most frequent complaints related to general anesthesia with tracheal intubation. Although sore throat is regarded as a minor and short-lasting discomfort after surgery, its incidence and intensity in high risk patients such as female gender, head and neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative recovery and give patient dissatisfaction. Even though the pathophysiology of post-intubation airway symptoms is not completely clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly used strategy to prevent postoperative airway discomfort after intubation. The preoperative administration of dexamethasone has been reported to reduce the incidence and severity of postoperative sore throat, but it is accompanied with the adverse effects such as hyperglycemia, delayed wound healing and increased infection in surgical patients. Ketorolac, non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used for postoperative pain control and has anti-inflammatory effect. Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in comparison to dexamethasone after thyroidectomy in female adult patients
Detailed description
Ketorolac, NSAID, has not been evaluated as a pharmacologic strategy to reduce postoperative sore throat yet. The investigator will explore how the analgesic and anti-inflammatory effects of ketorolac influence airway symptoms following general anesthesia with tracheal intubation.
Interventions
DRUGKetorolac
ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml
OTHERDexamethasone
dexamethasone acetate10 mg : total volume of 2 ml
DRUGPlacebo
Normal saline 2 ml
Sponsors
Yeungnam University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. American society of Anesthesiologists(ASA) physical status 1 and 2 2. 20-60 years old female 3. elective scheduled thyroidectomy
Exclusion criteria
surgery longer than 3 hours Previous history of or expected difficult tracheal intubation Laryngoscope grade (by Cormack and Lehane) of 3 or 4 2 more trial for intubation BMI \> 30 Hypersensitivity to ketorolac history of asthma respiratory tract infection during the past 6 weeks Renal dysfunction (creatinine \> 1.5 mg/dl or oligouria) Hepatic dysfunction (ALT :\> 50% more than normal value) Use of corticosteroid, NSAIDS, angiotensin converting enzyme in 10 days Medication for gastritis, gastric ulcer Upper gastrointestinal bleeding history Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | at 1, 6 and 24 hours after thyroidectomy | The investigator asked scales to patients at 1, 6 and 24h after extubation. POST was defined as discomfort at larynx or pharynx at rest and during swallowing after surgery and was assessed using a 4-grade scale (0-3) based on verbal responses to questions: 0, none; 1, mild (less severe than with a cold); 2, moderate (similar with a cold); 3 severe (more severe than with a cold) ● Incidence of sore throat : if patient rates sore throat scale more than 1, investigator will record as positive symptom. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | at 1, 6 and 24 hours after thyroidectomy | The investigator asked scales to patients at 1, 6 and 24h after extubation. PH was assessed using a 4-grade scale (0-3): 0, none; 1, mild (noticed by the patient only); 2, severe (obvious to observer); 3 aphonia (silence of voice) ● Incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign |
Other
| Measure | Time frame | Description |
|---|---|---|
| Potential Side Effects Associated With the Study Drugs | at 1, 6 and 24 hours after extubation | Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting. |
Countries
South Korea
Participant flow
Recruitment details
This study was conducted Yeungnam University Hospital in South korea from Oct. 2013 to Oct. 2015. One hundred and ninety - two female adults aged between 20 and 65 years, ASA physical status I or II scheduled for elective primary thyroidectomy under general anesthesia were enrolled.
Pre-assignment details
Patients with a airway problem, recent upper respiratory tract infection, obese, inflammation or hemorrhage in the upper gastrointestinal tract, use of NSAID or steroid medication, allergy to the general anesthetic used in this study were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery
Placebo: Normal saline 2 ml | 45 |
| Preketorolac Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml | 47 |
| Postketorolac Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery
Ketorolac: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml | 45 |
| Dexamethasone Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Dexamethasone: dexamethasone acetate10 mg : total volume of 2 ml | 43 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Cancellation of surgery | 0 | 0 | 1 | 0 |
| Overall Study | Duration of surgery > 3h | 1 | 1 | 0 | 0 |
| Overall Study | Loss of follow - up | 1 | 0 | 2 | 4 |
| Overall Study | Steroid Use | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal on concent | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Preketorolac | Postketorolac | Dexamethasone | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 47 Participants | 45 Participants | 43 Participants | 180 Participants |
| Age, Continuous | 48.2 years STANDARD_DEVIATION 10.1 | 49.5 years STANDARD_DEVIATION 9.2 | 47.3 years STANDARD_DEVIATION 9.3 | 46.0 years STANDARD_DEVIATION 11.1 | 47.8 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 45 Participants | 47 Participants | 45 Participants | 43 Participants | 180 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 47 | 0 / 45 | 0 / 43 |
| other Total, other adverse events | 0 / 45 | 0 / 47 | 0 / 45 | 0 / 43 |
| serious Total, serious adverse events | 0 / 45 | 0 / 47 | 0 / 45 | 0 / 43 |
Outcome results
Primary
The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
The investigator asked scales to patients at 1, 6 and 24h after extubation. POST was defined as discomfort at larynx or pharynx at rest and during swallowing after surgery and was assessed using a 4-grade scale (0-3) based on verbal responses to questions: 0, none; 1, mild (less severe than with a cold); 2, moderate (similar with a cold); 3 severe (more severe than with a cold) ● Incidence of sore throat : if patient rates sore throat scale more than 1, investigator will record as positive symptom.
Time frame: at 1, 6 and 24 hours after thyroidectomy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 1h | 43 Participants |
| Placebo | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 6h | 32 Participants |
| Placebo | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 24h | 20 Participants |
| Placebo | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 1h | 44 Participants |
| Placebo | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 6h | 44 Participants |
| Placebo | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 24h | 42 Participants |
| Preketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 24h | 37 Participants |
| Preketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 1h | 45 Participants |
| Preketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 1h | 44 Participants |
| Preketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 24h | 21 Participants |
| Preketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 6h | 34 Participants |
| Preketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 6h | 42 Participants |
| Postketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 6h | 33 Participants |
| Postketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 24h | 25 Participants |
| Postketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 1h | 44 Participants |
| Postketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 24h | 37 Participants |
| Postketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 6h | 40 Participants |
| Postketorolac | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 1h | 42 Participants |
| Dexamethasone | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 6h | 35 Participants |
| Dexamethasone | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 24h | 29 Participants |
| Dexamethasone | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 6h | 25 Participants |
| Dexamethasone | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Swallowing at 1h | 42 Participants |
| Dexamethasone | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 1h | 41 Participants |
| Dexamethasone | The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Sore throat Rest at 24h | 15 Participants |
Secondary
The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy
The investigator asked scales to patients at 1, 6 and 24h after extubation. PH was assessed using a 4-grade scale (0-3): 0, none; 1, mild (noticed by the patient only); 2, severe (obvious to observer); 3 aphonia (silence of voice) ● Incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign
Time frame: at 1, 6 and 24 hours after thyroidectomy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 1h | 42 Participants |
| Placebo | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 24h | 34 Participants |
| Placebo | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 6h | 37 Participants |
| Preketorolac | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 1h | 44 Participants |
| Preketorolac | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 24h | 28 Participants |
| Preketorolac | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 6h | 36 Participants |
| Postketorolac | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 6h | 39 Participants |
| Postketorolac | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 1h | 40 Participants |
| Postketorolac | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 24h | 29 Participants |
| Dexamethasone | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 1h | 40 Participants |
| Dexamethasone | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 24h | 22 Participants |
| Dexamethasone | The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy | Hoarseness at 6h | 35 Participants |
Other Pre-specified
Potential Side Effects Associated With the Study Drugs
Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.
Time frame: at 1, 6 and 24 hours after extubation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Potential Side Effects Associated With the Study Drugs | Nausea at 6h | 2 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Vomiting at 1h | 0 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Nausea at 24h | 0 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Vomiting at 6h | 0 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Analgesic use at 1h | 14 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Analgesic use at 6h | 2 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Vomiting at 24h | 0 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Analgesic use at 24h | 1 Participants |
| Placebo | Potential Side Effects Associated With the Study Drugs | Nausea at 1h | 10 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Nausea at 1h | 11 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Nausea at 6h | 7 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Vomiting at 6h | 2 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Vomiting at 24h | 0 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Analgesic use at 6h | 0 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Nausea at 24h | 1 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Analgesic use at 1h | 4 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Vomiting at 1h | 2 Participants |
| Preketorolac | Potential Side Effects Associated With the Study Drugs | Analgesic use at 24h | 0 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Vomiting at 1h | 1 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Vomiting at 6h | 1 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Vomiting at 24h | 0 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Analgesic use at 1h | 6 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Analgesic use at 6h | 0 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Nausea at 1h | 13 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Analgesic use at 24h | 0 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Nausea at 6h | 6 Participants |
| Postketorolac | Potential Side Effects Associated With the Study Drugs | Nausea at 24h | 2 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Vomiting at 24h | 0 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Nausea at 24h | 0 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Analgesic use at 1h | 9 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Analgesic use at 6h | 0 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Nausea at 1h | 15 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Nausea at 6h | 1 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Vomiting at 1h | 1 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Vomiting at 6h | 0 Participants |
| Dexamethasone | Potential Side Effects Associated With the Study Drugs | Analgesic use at 24h | 0 Participants |