A Phase 2/3 interventional study of Xylocaine in Postoperative Sore Throat, Cough, Hoarseness, sponsored by PAEC General Hospital, Islamabad. Active, not recruiting at 1 site in Pakistan. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by PAEC General Hospital, Islamabad · Phase 2/3, Interventional, and Prevention
Among 14 studies testing lidocaine in Cough — 2 open to participants now, 3 under way, 3 of them phase 3. Lidocaine · Cough.
Among the 14 studies testing lidocaine in Cough, this one is the 11th largest by enrollment, is one of 3 that started in 2025, is one of 2 in phase 2/3, and was the 14th registered.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →2 of the 14 studies testing lidocaine in Cough are open now, in 1 country. Each count lists the studies.
Lidocaine: first FDA approval 1948 (XYLOCAINE), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →
Of the 46 Cough studies recruiting now, 20 (43%) set no upper age limit and 14 (30%) stop at 75 or younger; 10 take children under 18; 6 take healthy volunteers.
This study: 13 Years and older · all sexes · healthy volunteers too.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2025.
Median enrollment 102 across the 14 interventional studies. Of the 7 that completed or were terminated, 0 (0%) have results posted.
None of the 14 has an industry lead sponsor. The 10 most frequent:
PAEC General Hospital, Islamabad is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
PAEC General Hospital, Islamabad has 1 study filed under Cough — fewer than ten, so there is no comparison to draw.
1 of the studies testing lidocaine in Cough that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07213037Phase 3Assiut UniversityMagnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sinus Surgery | 2026-11-01 |
Among the 14 studies testing lidocaine in Cough, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Xylocaine
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.
Drug: Xylocaine
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.
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
Time frame: 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)
Time frame: From extubation till 24 hours postoperatively
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.
Time frame: From enrollment till 24 hours postoperatively
Plan to share: No
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
PAEC General Hospital, Islamabad