Postoperative Sore Throat, Cough, HoarsenessPhase 4NCT01990781
Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.
A Phase 4 study testing LD: Lidocaine and dexamethasone, L:Lidocaine and D: Dexamethasone in people with Postoperative Sore Throat, Cough, Hoarseness, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
Post operative sore throat (POST) following tracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and dexamethasone has been used independently for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Sore Throat, Cough, Hoarseness
- What is being tested?
- LD: Lidocaine and dexamethasone, L:Lidocaine and D: Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteNepal
- Study dates
- Dec 2013to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of American Society of Anesthesiologist(ASA) physical status 1 \& 2 requiring general anesthesia with endotracheal intubation.
- Duration of surgery more than 90 min
Who cannot join
- Those with preexisting hoarseness or sorethroat
- Smoker
- Vocal performer by occupation
- Recent or recurrent respiratory tract infection
- Risk factors for postoperative aspiration
- Obesity
Show all 15Show fewer
- Pregnancy
- Receiving analgesics, corticosteroids and calcium channel blockers
- Contraindication to corticosteroid medications
- Anticipated difficult intubation
- Mallampati grade > 2
- Difficult mask ventilation requiring oral or nasal airway
- Cormack and Lehman grade III and IV on laryngoscopy
- More than one intubation attempt
- Those requiring orogastric or nasogastric tubes
Trial locations and contacts
1 site in 1 country.
Nepal1 site
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Koshi, 56700
About this study
Official title: Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial
Post operative sore throat (POST) following tracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and dexamethasone has been used independently for this purpose. However, there is no study assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine dexamethasone combination on the incidence and severity of POST.
Read the detailed description
Sore throat and hoarseness following tracheal intubation are common postoperative problems causing dissatisfaction and discomfort to the patients. Their incidence varies from 30%-70%.
Both non pharmacological and pharmacological measures have been tried to minimize the incidence and severity of POST with variable success rate. Prophylactic use lidocaine and steroids have been used independently for this purpose. Dexamethasone as an adjuvant to lidocaine has shown to improve the quality of analgesia. However, there is no study assessing the combine effects of lidocaine and dexamethasone for POST.
- Being tested
- LD: Lidocaine and dexamethasone, L:Lidocaine, D: Dexamethasone, N: Normal saline (placebo)
- Keywords
- Lidocaine, Dexamethasone, Postoperative sore throat
- Medical subject headings
- Cough, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LD: Lidocaine and dexamethasoneDrug
Also called Xylocard, dexona
LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia
L:LidocaineDrug
Also called Xylocard
Intravenous lidocaine 1.5 mg/kg before induction of anesthesia
D: DexamethasoneDrug
Also called Dexona
D:intravenous dexamethasone 8 mg before induction of anesthesia
N: Normal saline (placebo)Drug
Normal saline: 2ml
| Study group | Role | What they receive |
|---|---|---|
| Group LD: Lidocaine and Dexamethasone | Experimental | lidocaine 1.5 mg/kg and dexamethasone (dexona) 8 mg iv prior to induction of anesthesia Receives: Drug: LD: Lidocaine and dexamethasone |
| Group L: Lidocaine | Active comparator | Group L: lidocaine 1.5 mg/kg iv prior to induction of anesthesia Receives: Drug: L:Lidocaine |
| D: Dexamethasone | Active comparator | Dexamethasone 8 mg iv prior to induction of anesthesia Receives: Drug: D: Dexamethasone |
| N: normal saline | Placebo comparator | N: normal saline (placebo): 2 ml Receives: Drug: N: Normal saline (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative sore throat at rest and on swallowing.
Incidence of postoperative sore throat. Assessment of severity of postoperative sorethroat using scoring system, 0-No sore throat at any time since the operation,1- Minimal sore throat,2- Moderate sore throat,3- Severe sore throat
Measured: From 1 to 24 hr following surgery
Secondary outcomes (1)
-Assessment of post operative cough. Assessment of post operative cough using scoring system,0- No cough,1- Minimal cough,2- Moderate cough,3- Severe cough.
-Assessment of postoperative hoarseness. Assessment of postoperative hoarseness using scoring system,0- No evidence of hoarseness at any time since the operation,1-No evidence of hoarseness at the time of interview,2-Hoarseness at the time of interview noted by patient only, 3- Hoarseness that is easily noted at the time of interview
Measured: From 1 to 24 hr following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sore Throat, Cough, HoarsenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Asish Subedi, B.P. Koirala Institute of Health Sciences
- Investigators
- Asish Subedi, MD, Principal investigator, BPKIHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990781
- Sponsor's protocol ID
- 387/070/071
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2013
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Subedi A, Tripathi M, Pokharel K, Khatiwada S. Effect of Intravenous Lidocaine, Dexamethasone, and Their Combination on Postoperative Sore Throat: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):220-225. doi: 10.1213/ANE.0000000000003842.
PubMed 30320641
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01990781
- Acronym / sponsor ID
- 387/070/071
- Keywords
- Lidocaine, Dexamethasone, Postoperative sore throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post operative sore throat (POST) following tracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. Prophylactic use of both lidocaine and dexamethasone has been used independently for this purpose. However, there is no study assessing the synergistic analgesic effects of lidocaine and dexamethasone for POST. The purpose of this study is to compare the effect of lidocaine, dexamethasone and lidocaine dexamethasone combination on the incidence and severity of POST.
Detailed description
Sore throat and hoarseness following tracheal intubation are common postoperative problems causing dissatisfaction and discomfort to the patients. Their incidence varies from 30%-70%.
Both non pharmacological and pharmacological measures have been tried to minimize the incidence and severity of POST with variable success rate. Prophylactic use lidocaine and steroids have been used independently for this purpose. Dexamethasone as an adjuvant to lidocaine has shown to improve the quality of analgesia. However, there is no study assessing the combine effects of lidocaine and dexamethasone for POST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group LD: Lidocaine and Dexamethasone | Experimental | Drug: LD: Lidocaine and dexamethasonelidocaine 1.5 mg/kg and dexamethasone (dexona) 8 mg iv prior to induction of anesthesia |
| Group L: Lidocaine | Active comparator | Drug: L:LidocaineGroup L: lidocaine 1.5 mg/kg iv prior to induction of anesthesia |
| D: Dexamethasone | Active comparator | Drug: D: DexamethasoneDexamethasone 8 mg iv prior to induction of anesthesia |
| N: normal saline | Placebo comparator | Drug: N: Normal saline (placebo)N: normal saline (placebo): 2 ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of American Society of Anesthesiologist(ASA) physical status 1 \& 2 requiring general anesthesia with endotracheal intubation.
- Duration of surgery more than 90 min
Key exclusion criteria (15 listed)
- Those with preexisting hoarseness or sorethroat
- Smoker
- Vocal performer by occupation
- Recent or recurrent respiratory tract infection
- Risk factors for postoperative aspiration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LD: Lidocaine and dexamethasoneAlso: Xylocard, dexonaLD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia | Drug | Group LD: Lidocaine and Dexamethasone |
| L:LidocaineAlso: XylocardIntravenous lidocaine 1.5 mg/kg before induction of anesthesia | Drug | Group L: Lidocaine |
| D: DexamethasoneAlso: DexonaD:intravenous dexamethasone 8 mg before induction of anesthesia | Drug | D: Dexamethasone |
| N: Normal saline (placebo)Normal saline: 2ml | Drug | N: normal saline |
Primary outcome
Assessment of postoperative sore throat at rest and on swallowing.
Time frame: From 1 to 24 hr following surgery
Incidence of postoperative sore throat. Assessment of severity of postoperative sorethroat using scoring system, 0-No sore throat at any time since the operation,1- Minimal sore throat,2- Moderate sore throat,3- Severe sore throat
1 secondary outcome
-Assessment of post operative cough. Assessment of post operative cough using scoring system,0- No cough,1- Minimal cough,2- Moderate cough,3- Severe cough.
Time frame: From 1 to 24 hr following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Derived from this study: PubMed 30320641Subedi A, Tripathi M, Pokharel K, Khatiwada S. Effect of Intravenous Lidocaine, Dexamethasone, and Their Combination on Postoperative Sore Throat: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):220-225. doi: 10.1213/ANE.0000000000003842.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asish Subedi, MD principal investigator
BPKIHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LD: Lidocaine and dexamethasone, L:Lidocaine and D: Dexamethasone in people with Postoperative Sore Throat, Cough, Hoarseness, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative sore throat at rest and on swallowing. (time frame: From 1 to 24 hr following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.