Postoperative Sore Throat, Cough, HoarsenessPhase 2/3NCT07315490
Air Versus Lignocaine for Endotracheal Tube Cuff Inflation and Effect on Postoperative Sore Throat and Intracuff Pressure
A Phase 2/3 study testing Xylocaine in people with Postoperative Sore Throat, Cough, Hoarseness, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
Trial summary
Endotracheal Tube (ETT) is frequently used for GA (general anesthesia) to deliver oxygen and volatile anesthetic agents to the patient and serves as a channel for anesthetic gases. The ETT cuff helps in positive pressure ventilation and maintains an adequate seal between the endotracheal tube and trachea. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sore Throat, Cough, Hoarseness
- What is being tested?
- Xylocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Aug 2025to 20 Jan 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA (American Society of Anaesthesiologists) I and II
- Male/Female
- Age group 18 - 55 years
- Patient undergoing surgery under general anesthesia.
- Patients undergoing surgery in supine/ Trendelenburg position.
Who cannot join
- ASA III and IV
- Patients with preoperative history of cough or sore throat
- Patients undergoing nose, throat, or airway surgery.
- Patients with history of allergic diseases
- Patient with known pulmonary disease
- Patients in whom more than 1 attempt on intubation is done
- Patients who may need postoperative ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effect of Air Versus Lignocaine for Endotracheal Tube Cuff Inflation on Postoperative Sore Throat and Intracuff Pressure
Endotracheal Tube (ETT) is frequently used for GA (general anesthesia) to deliver oxygen and volatile anesthetic agents to the patient and serves as a channel for anesthetic gases. The ETT cuff helps in positive pressure ventilation and maintains an adequate seal between the endotracheal tube and trachea.
Prolonged inflation of ETT cuff can cause ischemic changes of tracheal mucosa and other complications like postoperative sore throat (POST), hoarseness of voice, difficulty in swallowing, tracheal wall ulcer, stricture etc. Among these, the occurrence of sore throat after GA ranges from 21 - 65% Hence it important to measure ETT cuff pressure in intubated patients. The reliable and convenient way for this is using an ETT manometer, which is not readily available in most of hospitals in Pakistan.Many studies have focused on incidence of POST. Most of these studies have been done in western population and differences in various ethnicities are well reported . In Pakistan, air is widely used for ETT cuff inflation.
If the results depict minimal cuff pressure changes and postoperative side effects with Xylocaine as compared to air, then it can be inferred that cuff pressure does not increase due to N2O when Xylocaine is used, hence, it can be safely used for cuff inflation eliminating the requirement of ETT cuff pressure monitoring and also the ETT cuff manometer, serving as a cost-effective alternative.
Read the detailed description
Every patient will be evaluated in the preoperative clinic where detailed present and past history including any current illness, medication, previous surgeries and addiction will be taken and recorded. Also baseline investigations will be evaluated. Airway examination and Mallampati scoring will be done. The patients will be divided into 2 groups: Group A (Air) and Group X (Xylocaine plain 2%), using air and Xylocaine for alternate patients.
In the OT, an anesthesia resident will record baseline vitals. An IV line with 18 or 20 G cannula will be secured and IV fluid Ringer Lactate will be infused according to the body weight. All patients will be preoxygenated for 3min. Patients will be premedicated Ondansetron 0.8mg/kg, Glycopyrrolate 0.2mg/kg, Dexamethasone 8mg, inducted with Propofol 2mg/kg, Atracurium 0.5mg/kg. Anesthesia will be maintained with Oxygen 50%, Nitrous oxide 50% and Isoflurane. Patient will be intubated with a cuffed ETT, size 7 or 7.5 mm for males and 6.5 or 7mm for females. For Group A the cuff of the ETT will be inflated with air and for Group X the ETT cuff will be inflated with Xylocaine plain 2% and the ETT cuff pressure will be measured by an anesthesia assistant using cuff manometer immediately after intubation and at 5, 15, 30min and then at every 30 min till the completion of surgery.
On completion of surgery, anesthesia will be reversed by weaning of the anesthetic gases and neostigmine 0.05-0.07mg/kg with glycopyrrolate will be used to reverse the remaining muscle paralysis. When the patient is awake the ETT cuff will be deflated by removing the inflating agent. Then the patient will be oxygenated with a face mask until needed. Signs and symptoms like postoperative sore throat, cough and hoarseness of voice will be recorded immediately after extubation and at 30min, 6hr and 24 hr post operatively. The severity of POST will be scored on a scale of 0-3 (0: No POST; 1: Mild; 2: Moderate; 3: Severe).
- Being tested
- Xylocaine
- Keywords
- Endotacheal Tube, General Anesthesia, Air, ETT cuff, Xylocaine, Post operative sore throat, ETT cuff Manometer, Cough, Sore throat, Hoarseness of voice, Intra cuff pressure
- Medical subject headings
- Cough, Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylocaineDrug
In patients undergoing surgeries under GA, xylocaine will be used for 50% subjects and ETT cuff pressures will be measured at regular and compated to air to study if using xylocaine can abolish the affect of Nitrous oxide on intracuff air pressure. Also postoperatively, POST scoring will be done.
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine | Experimental | In 50% of subjects undergoing surgeriws under GA, Xylocaine will be used for ETT cuff inflation. Intracuff pressures will be measured every 15 mins using ETT cuff manometer and compared with intracuff air.Postoperative POST scoring will be done to study its effect on postopertaive sorethroat and incidence will weighed against intracuff air. Receives: Drug: Xylocaine |
| Air | Placebo comparator | In 50% of subjects undergoing surgeries under GA, air will be ussed for ETT cuff inflation, intracuff pressures will be measured every 15 min POST scoring will be done postoperatively. Receives: Drug: Xylocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of ETT cuff Pressure
Patients will be divided in 2 groups on basis of the medium used for ETT cuff infalation (Air or Xylocaine) and intracuff pressure will be measured using ETT cuff manometer immediately after intubation, at 5min, 15min, 30min and then eveey 30 min till completion of surgery
Measured: From the time of intubation till extubation
Postoperative Sorethroat, Cough and Hoarseness
This will be measured immediately after extubation, at 30min, 6hrs and 24 hours postoperative using POST (postoperative sorethroat) scoring scale for both groups of subjects and responses will be compared.
Sorethroat (grade 0-3; where 0 stand for no sorethroat and 3 stand for severe sorethroat) Cough (grade 0-3; where 0 stand for no cough and 3 stand for severe cough) Hoarseness of Voice (grade 0-3; where 0 stand for no hoarseness and 3 stand for severe hoarseness)
Measured: From extubation till 24 hours postoperatively
Secondary outcomes (1)
Demographic data
Age: can affect airway anatomy (loss of elasticity, missing or loose teeth) BMI: higher malampatti scores, difficult intubation (kg/m²) Gender: structural airway differences, different ETT sizes Difficulty of intubation: directly related to airway trauma Duration of surgery: directly related to increase in cuff pressures in N2O anesthesia (in minutes) ASA physical status: according to classification given by Amercian Society of Anesthesiologists, will be done preoperatively.
Measured: From enrollment till 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start2 Aug 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAEC General Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubaria Liaquat, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315490
- Sponsor's protocol ID
- PGHI-IRB (DMe)-RCD-06-096
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effect of Air Versus Lignocaine for Endotracheal Tube Cuff Inflation on Postoperative Sore Throat and Intracuff Pressure
- ClinicalTrials.gov ID
- NCT07315490
- Acronym / sponsor ID
- PGHI-IRB (DMe)-RCD-06-096
- Keywords
- Endotacheal Tube, General Anesthesia, Air, ETT cuff, Xylocaine, Post operative sore throat, ETT cuff Manometer, Cough
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PAEC General Hospital, IslamabadUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- 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.
Endotracheal Tube (ETT) is frequently used for GA (general anesthesia) to deliver oxygen and volatile anesthetic agents to the patient and serves as a channel for anesthetic gases. The ETT cuff helps in positive pressure ventilation and maintains an adequate seal between the endotracheal tube and trachea.
Prolonged inflation of ETT cuff can cause ischemic changes of tracheal mucosa and other complications like postoperative sore throat (POST), hoarseness of voice, difficulty in swallowing, tracheal wall ulcer, stricture etc. Among these, the occurrence of sore throat after GA ranges from 21 - 65% Hence it important to measure ETT cuff pressure in intubated patients. The reliable and convenient way for this is using an ETT manometer, which is not readily available in most of hospitals in Pakistan.Many studies have focused on incidence of POST. Most of these studies have been done in western population and differences in various ethnicities are well reported . In Pakistan, air is widely used for ETT cuff inflation.
If the results depict minimal cuff pressure changes and postoperative side effects with Xylocaine as compared to air, then it can be inferred that cuff pressure does not increase due to N2O when Xylocaine is used, hence, it can be safely used for cuff inflation eliminating the requirement of ETT cuff pressure monitoring and also the ETT cuff manometer, serving as a cost-effective alternative.
Detailed description
Every patient will be evaluated in the preoperative clinic where detailed present and past history including any current illness, medication, previous surgeries and addiction will be taken and recorded. Also baseline investigations will be evaluated. Airway examination and Mallampati scoring will be done. The patients will be divided into 2 groups: Group A (Air) and Group X (Xylocaine plain 2%), using air and Xylocaine for alternate patients.
In the OT, an anesthesia resident will record baseline vitals. An IV line with 18 or 20 G cannula will be secured and IV fluid Ringer Lactate will be infused according to the body weight. All patients will be preoxygenated for 3min. Patients will be premedicated Ondansetron 0.8mg/kg, Glycopyrrolate 0.2mg/kg, Dexamethasone 8mg, inducted with Propofol 2mg/kg, Atracurium 0.5mg/kg. Anesthesia will be maintained with Oxygen 50%, Nitrous oxide 50% and Isoflurane. Patient will be intubated with a cuffed ETT, size 7 or 7.5 mm for males and 6.5 or 7mm for females. For Group A the cuff of the ETT will be inflated with air and for Group X the ETT cuff will be inflated with Xylocaine plain 2% and the ETT cuff pressure will be measured by an anesthesia assistant using cuff manometer immediately after intubation and at 5, 15, 30min and then at every 30 min till the completion of surgery.
On completion of surgery, anesthesia will be reversed by weaning of the anesthetic gases and neostigmine 0.05-0.07mg/kg with glycopyrrolate will be used to reverse the remaining muscle paralysis. When the patient is awake the ETT cuff will be deflated by removing the inflating agent. Then the patient will be oxygenated with a face mask until needed. Signs and symptoms like postoperative sore throat, cough and hoarseness of voice will be recorded immediately after extubation and at 30min, 6hr and 24 hr post operatively. The severity of POST will be scored on a scale of 0-3 (0: No POST; 1: Mild; 2: Moderate; 3: Severe).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylocaine | Experimental | Drug: XylocaineIn 50% of subjects undergoing surgeriws under GA, Xylocaine will be used for ETT cuff inflation. Intracuff pressures will be measured every 15 mins using ETT cuff manometer and compared with intracuff air.Postoperative POST scoring will be done to study its effect on postopertaive sorethroat and incidence will weighed against intracuff air. |
| Air | Placebo comparator | Drug: XylocaineIn 50% of subjects undergoing surgeries under GA, air will be ussed for ETT cuff inflation, intracuff pressures will be measured every 15 min POST scoring will be done postoperatively. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ASA (American Society of Anaesthesiologists) I and II
- Male/Female
- Age group 18 - 55 years
- Patient undergoing surgery under general anesthesia.
- Patients undergoing surgery in supine/ Trendelenburg position.
Key exclusion criteria (7 listed)
- ASA III and IV
- Patients with preoperative history of cough or sore throat
- Patients undergoing nose, throat, or airway surgery.
- Patients with history of allergic diseases
- Patient with known pulmonary disease
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 |
|---|---|---|
| XylocaineIn patients undergoing surgeries under GA, xylocaine will be used for 50% subjects and ETT cuff pressures will be measured at regular and compated to air to study if using xylocaine can abolish the affect of Nitrous oxide on intracuff air pressure. Also postoperatively, POST scoring will be done. | Drug | Air, Xylocaine |
Primary outcome
Measurement of ETT cuff Pressure
Time frame: From the time of intubation till extubation
Patients will be divided in 2 groups on basis of the medium used for ETT cuff infalation (Air or Xylocaine) and intracuff pressure will be measured using ETT cuff manometer immediately after intubation, at 5min, 15min, 30min and then eveey 30 min till completion of surgery
Postoperative Sorethroat, Cough and Hoarseness
Time frame: From extubation till 24 hours postoperatively
This will be measured immediately after extubation, at 30min, 6hrs and 24 hours postoperative using POST (postoperative sorethroat) scoring scale for both groups of subjects and responses will be compared. Sorethroat (grade 0-3; where 0 stand for no sorethroat and 3 stand for severe sorethroat) Cough (grade 0-3; where 0 stand for no cough and 3 stand for severe cough) Hoarseness of Voice (grade 0-3; where 0 stand for no hoarseness and 3 stand for severe hoarseness)
1 secondary outcome
Demographic data
Time frame: From enrollment till 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Changes in endotracheal tube cuff pressures and incidence of post-operative sore throat while using different inflating agentsLink provided by the sponsor.
- Postoperative Sore Throat Following General Surgical Procedures under General Anesthesia with Endotracheal IntubationLink provided by the sponsor.
- Effect of Air versus 1% Lignocaine used for Endotracheal Tube Cuff Inflation on Laryngotracheal Morbidity after Laparoscopic Surgery- A Randomised Clinical StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Xylocaine in people with Postoperative Sore Throat, Cough, Hoarseness, run by PAEC General Hospital, Islamabad at 1 site in Pakistan.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. 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 Pakistan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Measurement of ETT cuff Pressure (time frame: From the time of intubation till extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.