Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
When a surgical procedure is performed under general anesthesia, the Airways are often secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies have shown a reduction of these side effects when by use of muscle relaxants or a lidocain spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the two methods or nothing. These methods will be studied systematically.
Heart rate and blood pressure rise during the intubation procedure. The investigators will also study the differences between the groups.
Post-operative sore throat and cough are common complications of endotracheal intubation and occurs in 30% to 70% of patients. Spraying with Lidocaine reduces this incident of postoperative sore Throat (POST). The use of neuromuscular blocking agents (NMBA) alone will also diminish the incidence of adverse postoperative upper airway symptoms. The use of topical Lidocaine is shown to reduce the cardiovascular responses during and after endotracheal intubation.
Hypertension and tachycardia as a response to endotracheal intubation are probably of little consequence in healthy individuals. These reactions might though be harmful in patients with cardiovascular diseases.
Postoperative sore throat is an undesired outcome for the patient. Topical or systemic pharmacological interventions is shown to reduce the POST.
Our anesthetists practice very different. The investigators sometime use topical lidocaine 2% as a spray, sometime muscle relaxants and often nothing but propofol and remifentanil prior to laryngoscopy an endotracheal intubation.
The objective of this study is to determine, whether the use of topical administered lidocaine, 2 %, has a better impact on POST compared with NMBA alone in general anesthesia with propofol and remifentanil. Patients receiving nothing but propofol and remifentanil will be the reference group. Assessment of the intubation conditions will be done according to a standard scheme
The primary endpoint:
The secondary endpoint:
• Post operative upper airways symptoms. Power and Sample Size Calculator To detect a decrease in the incidence of pharyngolaryngeal symptoms from 60% to 45%, we calculated that we needed 150 patients per study arm (power of the study, 0,8; type I error, 0,05).
450 adult patients have to be scheduled for the study.
The study is double blind, randomized:
Postoperatively:
Collected data:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine spray | Other | Endotracheal lidocaine spray prior to intubation |
|
| Muscle relaxant | Other | Muscle relaxant prior to intubation |
|
| No Muscle relaxant, no Lidocaine | Other | 'No Muscle relaxant, no Lidocaine Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine spray (2%) | Drug | Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sore Throat postoperative. Assessment of complaints and changes in complaints | Postoperative sore throat, described 2 h and 24 h after extubation. If the patient has sore throat or is hoarse, the complaint is assessed on a VAS (Visual Analogue Scale) 1 - 10. | 2 h and 24 h after extubation |
| Intubation conditions directly after induction of anesthesia | Describes the intubation conditions: Jaw relaxation, resistance to laryngoscopy blade, the position and movement of vocal cords, the movement of limbs and coughing. Each variable rates as excellent, good or poor. Intubation conditions are many variables described once and should not be divided into several outcomes. | 90 sec. after established general anesthesia |
| Hemodynamic parameters, change in HR (Heart Rate) is being assessed | Describes changes in HR (Heart Rate) | Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.) |
| Hemodynamic parameters, change in BP (blood pressure) is being assessed | Describes changes in BP(Blood Pressure) | Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Sverre Vamnes, MD, Ph.D | Contact | +47 913 05 016 | jan.sverre.vamnes@so-hf.no | |
| Knut Inge Solbakk, MD | Contact | +47 909 33 106 | knut.inge.solbakk@so-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Jan Sverre Vamnes, MD, Ph.D. | Senior consultant | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ostfold Hospital Trust, Moss | Recruiting | Grålum | Østfold fylke | 1714 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26082898 | Background | Banihashem N, Alijanpour E, Hasannasab B, Zarei A. Prophylactic Effects of Lidocaine or Beclomethasone Spray on Post-Operative Sore Throat and Cough after Orotracheal Intubation. Iran J Otorhinolaryngol. 2015 May;27(80):179-84. | |
| 11094588 | Background | Blobner M, Mirakhur RK, Wierda JM, Wright PM, Olkkola KT, Debaene B, Pendeville P, Engbaek J, Rietbergen H, Sparr HJ. Rapacuronium 2.0 or 2.5 mg kg-1 for rapid-sequence induction: comparison with succinylcholine 1.0 mg kg-1. Br J Anaesth. 2000 Nov;85(5):724-31. doi: 10.1093/bja/85.5.724. |
Not provided
Not provided
No sharing plan so far.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Muscle Relaxant (Rocuronium) | Drug | After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously. |
|
|
| No Muscle relaxant, no Lidocaine | Other | This group get general anesthesia without Rocuronium or Lidocaine |
|
|
| 17573390 | Background | Combes X, Andriamifidy L, Dufresne E, Suen P, Sauvat S, Scherrer E, Feiss P, Marty J, Duvaldestin P. Comparison of two induction regimens using or not using muscle relaxant: impact on postoperative upper airway discomfort. Br J Anaesth. 2007 Aug;99(2):276-81. doi: 10.1093/bja/aem147. Epub 2007 Jun 15. |
| 1167764 | Background | Domaoal AM, Weniger FC, Wolfson B. "Precurarization" using pancuronium. Anesth Analg. 1975 Jan-Feb;54(1):71-5. doi: 10.1213/00000539-197501000-00014. |
| 25999003 | Background | Doyle DJ. Airway anesthesia: theory and practice. Anesthesiol Clin. 2015 Jun;33(2):291-304. doi: 10.1016/j.anclin.2015.02.013. |
| 25109156 | Background | Kalil DM, Silvestro LS, Austin PN. Novel preoperative pharmacologic methods of preventing postoperative sore throat due to tracheal intubation. AANA J. 2014 Jun;82(3):188-97. |
| 2890365 | Background | Martin C, Bonneru JJ, Brun JP, Albanese J, Gouin F. Vecuronium or suxamethonium for rapid sequence intubation: which is better? Br J Anaesth. 1987 Oct;59(10):1240-4. doi: 10.1093/bja/59.10.1240. |
| 10084094 | Background | Mostafa SM, Murthy BV, Barrett PJ, McHugh P. Comparison of the effects of topical lignocaine spray applied before or after induction of anaesthesia on the pressor response to direct laryngoscopy and intubation. Eur J Anaesthesiol. 1999 Jan;16(1):7-10. doi: 10.1046/j.1365-2346.1999.00410.x. |
| 7741805 | Background | Koller ME, Husby P. High-dose vecuronium may be an alternative to suxamethonium for rapid-sequence intubation. Acta Anaesthesiol Scand. 1993 Jul;37(5):465-8. doi: 10.1111/j.1399-6576.1993.tb03747.x. |
| 23839320 | Background | Qi DY, Wang K, Zhang H, Du BX, Xu FY, Wang L, Zou Z, Shi XY. Efficacy of intravenous lidocaine versus placebo on attenuating cardiovascular response to laryngoscopy and tracheal intubation: a systematic review of randomized controlled trials. Minerva Anestesiol. 2013 Dec;79(12):1423-35. Epub 2013 Jul 9. |
| 19588349 | Background | Tanaka Y, Nakayama T, Nishimori M, Sato Y, Furuya H. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD004081. doi: 10.1002/14651858.CD004081.pub2. |
| 8904261 | Background | Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. doi: 10.1111/j.1399-6576.1996.tb04389.x. |
| D011083 |
| Polycyclic Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |