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The purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.
The diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. Studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. No study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alkalized lidocaine | Active Comparator | 160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal. |
|
| Sterile saline | Placebo Comparator | 4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal intubation with injection of liquid in the cuff | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coughing | 24 hours after the end ofsurgery |
| Measure | Description | Time Frame |
|---|---|---|
| Throat pain | 24 hours after the end of surgery | |
| Nausea and Vomiting | 24 hours after end of surgery | |
| Hoarseness of the voice |
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Inclusion Criteria:
- ASA 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanick Sansoucy, Doctor | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14970135 | Background | Estebe JP, Delahaye S, Le Corre P, Dollo G, Le Naoures A, Chevanne F, Ecoffey C. Alkalinization of intra-cuff lidocaine and use of gel lubrication protect against tracheal tube-induced emergence phenomena. Br J Anaesth. 2004 Mar;92(3):361-6. doi: 10.1093/bja/aeh078. | |
| 16244028 | Background | Estebe JP, Gentili M, Le Corre P, Dollo G, Chevanne F, Ecoffey C. Alkalinization of intracuff lidocaine: efficacy and safety. Anesth Analg. 2005 Nov;101(5):1536-1541. doi: 10.1213/01.ANE.0000180995.24211.89. |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| 24 hours after end of surgery |
| 11772834 | Background | Estebe JP, Dollo G, Le Corre P, Le Naoures A, Chevanne F, Le Verge R, Ecoffey C. Alkalinization of intracuff lidocaine improves endotracheal tube-induced emergence phenomena. Anesth Analg. 2002 Jan;94(1):227-30, table of contents. doi: 10.1097/00000539-200201000-00044. |
| 11384855 | Background | Dollo G, Estebe JP, Le Corre P, Chevanne F, Ecoffey C, Le Verge R. Endotracheal tube cuffs filled with lidocaine as a drug delivery system: in vitro and in vivo investigations. Eur J Pharm Sci. 2001 Jun;13(3):319-23. doi: 10.1016/s0928-0987(01)00119-1. |
| 22569622 | Background | Navarro LH, Lima RM, Aguiar AS, Braz JR, Carness JM, Modolo NS. The effect of intracuff alkalinized 2% lidocaine on emergence coughing, sore throat, and hoarseness in smokers. Rev Assoc Med Bras (1992). 2012 Mar-Apr;58(2):248-53. |
| 27075030 | Derived | Souissi H, Frechette Y, Murza A, Masse MH, Marsault E, Sarret P, D'Aragon F, Parent AJ, Sansoucy Y. Intracuff 160 mg alkalinized lidocaine reduces cough upon emergence from N2O-free general anesthesia: a randomized controlled trial. Can J Anaesth. 2016 Jul;63(7):862-70. doi: 10.1007/s12630-016-0652-8. Epub 2016 Apr 13. |
| D013568 | Pathological Conditions, Signs and Symptoms |