A Phase 4 interventional study of Intravenous lignocaine and Normal Saline (0.9% NaCl) in Postoperative Sore Throat, Cough, Hoarseness, Postoperative Complications and Intravenous Lidocaine, sponsored by University of Malaya. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by University of Malaya · Phase 4, Interventional, and Prevention
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Among 15 studies testing lidocaine in Cough — 3 open to participants now, 4 under way, 3 of them phase 3. Lidocaine · Cough.
Among the 15 studies testing lidocaine in Cough, this one is the 2nd largest by planned enrollment, is the only one that started in 2027, is one of 4 in phase 4, and was the 15th registered.
428 studies on the registry are indexed under Cough; 68 are open to participants now.
Browse Cough studies →3 of the 15 studies testing lidocaine in Cough are open now, in 2 countries. Recruiting first, the newest first:
Al-Azhar University · Sites in Egypt
Ages 21–60
Assiut University
Ages 18–70
By country, each count listing its 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: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 6 · Phase 4 4
First in 2012; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 398 is above the median of 80 across 320 interventional studies indexed under Cough.
Median enrollment 102 across the 15 interventional studies. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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None of the 15 has an industry lead sponsor. The 10 most frequent:
University of Malaya is the lead sponsor of 285 studies on the registry; 59 are open to participants now.
University of Malaya has 1 study filed under Cough — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing lidocaine in Cough, from their registry updates:
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Patients often encounter unpleasant sore throat after surgery when wake up from general anaesthesia and pulling off breathing tube. Lignocaine is a medication used in anaesthesia for the properties of analgesia and anti-inflammation. Other studies suggested that lignocaine spray/ gel can reduce the postoperative sore throat after extubation in patients undergoing surgery. However, it can reduce the gag reflex, resulting in higher risk of aspiration after surgery. Therefore, this randomized, double-blind, placebo-controlled trial is designed to determine whether giving intravenous lignocaine toward the end of the surgery before extubation can reduce postoperative sore throat and discomfort after surgery. It is hypothesized that intravenous lignocaine can reduce postoperative sore throat in patients undergoing general anaesthesia.
Postoperative sore throat (POST) is a common and discomfort adverse event following general anaesthesia with orotracheal intubation, with reported incidences ranging from 30% to 70%. It is characterized by pain or discomfort at the larynx or pharynx during postoperative period in the recovery area, which can affect the overall perioperative experience and patient satisfaction. The pathophysiology of POST is believed due to mechanical trauma to the pharyngeal and laryngeal mucosa during intubation, cuff-related pressure injury, and airway inflammation that cause postoperative throat symptoms. Several non-pharmacological and pharmacological measures such as lozenges, gargles, lignocaine spray and steroid injection have been experimented with mixed findings.
Lignocaine is a local anaesthetic agent, which has the properties of analgesia and anti-inflammatory effect via the blockade of sodium channel receptor. Lignocaine spray at the throat is believed to reduce the severity of POST at various concentration (2%, 5% and 10%). However, studies reported that some of the additives agents (methanol, ethanol) in the lignocaine spray have irritating side effects to damage tracheal mucosa, negating the effect of topical lignocaine on the incidence of POST. In addition, topicalized lignocaine reduces the gag reflex if given too late before extubation, resulting in higher risk of aspiration in the recovery area.
In a routine general anaesthesia, intravenous dexamethasone is administered as an analgesic adjunct and anti-inflammatory to minimize airway edema. Administering intravenous lignocaine prior to extubation is believed to provide analgesic effect to reduce incidence of POST and postoperative cough after general anaesthesia. However, the evidence regarding its effect on POST remains limited and inconsistent, particularly when administered near the time of emergence from general anaesthesia.
Therefore, this randomized, double-blind, placebo-controlled trial is aimed to examine the use of intravenous lignocaine prior to extubation in the reduction of POST in surgical patients undergoing oral intubation during general anaesthesia in University Malaya Medical Centre.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Intravenous lignocaine
Drug: Normal Saline (0.9% NaCl)
IV lignocaine 1.5 mg/kg, calculated on lean body weight (LBW).
0.9% normal saline
Incidence of postoperative sore throat (POST)
Patient-reported pain/discomfort in throat (yes/no) on standardised question.
Time frame: 1-hour, 6-hour, 24-hour after surgery
Severity of POST
NRS 0-10 (0 = none, 10 = worst imaginable).
Time frame: 1-hour, 6-hour, 24-hour after surgery
Incidence and severity of postoperative cough
Observation of cough in post anaesthesia care unit (yes/no); 4-point scale: 0 none, 1 mild (single), 2 moderate (\> 1 episode), 3 severe (constant).
Time frame: 1-hour, 6-hour, 24-hour after surgery
Incidence of post-extubation hoarseness
Stout's 4-point grading: 0 no hoarseness, 1 mild hoarseness (only noticed by patient), 2 severe hoarseness (noticed by medical personnel), 3 aphonia (total inability to speak)
Time frame: 1-hour, 6-hour, 24-hour after surgery
Patient satisfaction
NRS 0-10 (0 = not satisfy, 10 = very satisfy)
Time frame: 24-hour after surgery
Adverse events of intravenous lignocaine
haemodynamic events (HR \< 50 or \> 100, MAP \< 65 or \> 110); seizure, perioral numbness, dizziness, tinnitus.
Time frame: During surgery and 1-hour after surgery in post anaesthesia care unit
Plan to share: No — Requests for de-identified data from qualified researchers may be considered by the principal investigator on a case-by-case basis, subject to approval by the ethics committee.
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 20 phase 4 interventional studies under Cough, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine