An interventional study of Alkalinized lidocaine and Saline in Cough and Anesthesia, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-01.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Prevention
This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with alkalinized lidocaine on the:
The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control group following a desflurane-based anesthesia.
Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.
Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia. Different techniques and drugs have been studied to reduce coughing during emergence.
Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. Intracuff lidocaine has been shown to increase the tolerance to the endotracheal tube without reducing the swallowing reflex. However, lidocaine slowly diffuses across the tube's cuff. The addition of bicarbonates is required to increase its diffusion to the underlying tracheal tissue. Alkalinization of lidocaine allows the diffusion of 65% of its neutral base form over a period of 6 hours.
In vitro studies have demonstrated that the optimal time for local anesthetic diffusion through the cuff may vary from 90 to 180 minutes. Due to its low onset, this technique would be appropriate for long-duration surgeries. Pre-filling the endotracheal tube cuffs with alkalinized lidocaine at least 90 minutes before intubation could be appropriate for surgeries expected to last less than two hours.
This study will assess the efficacy of pre-filling endotracheal tube cuffs with alkalinized lidocaine to prevent coughing during emergence in short-duration surgeries.
355 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 200 is above the median of 71 across 270 interventional studies indexed under Cough.
Browse Cough studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
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The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with alkalinized lidocaine. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube). During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.
Drug: Alkalinized lidocaine
The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with saline. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube). During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.
Drug: Saline
Administration of alkalinized lidocaine in the endotracheal tube cuff
Administration of saline in the endotracheal tube cuff
Incidence of coughing during emergence of general anesthesia
Time frame: At extubation (Day 0)
Time to emergence
Time frame: At extubation (Day 0)
Incidence of sore throat
Time frame: One hour after extubation (Day 0)
The record gives a start of Jan 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
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