Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant on Sore Throat and Hemodynamics

Intubation Complication Clinical Trial

Official title:

Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant; Impact on Postoperative Sore Throat and Haemodynamics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03031808
• Other study ID #: AB3383
• Status: Recruiting
• Phase: Phase 4
• Start date: October 31, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Ostfold Hospital Trust
• Contact: Jan Sverre Vamnes, MD, Ph.D
• Phone: +47 913 05 016
• Email: jan.sverre.vamnes[@]so-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• Differences in the intubation conditions between the three groups.

• Cardiovascular responses caused by the laryngoscopy and intubation.

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:

• Group Topical lidocaine 4%:

• Group NMBA

• Control group Premedication: Paracetamol 2g General anaesthesia: TCI (Target Control of Infusion is a principle, an anesthesia infusion after protocol): Propofol and Remifentanil Surgical procedure: Not specified short lasting (<1 h) procedures The experienced anesthesiologist performing the intubating procedure will not be in the room until immediately before the intubation.

Postoperatively:

• Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively, every 6 h

• When nausea and vomiting occurs postoperatively, ondansetron 4 mg IV administers as the drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.

Collected data:

• Patient characteristics inclusive smoke habits

• Intubation conditions according to the Copenhagen score

• Blood pressure prior to laryngoscopy and after 1, 3, 5, 7, 9, 11, 13 and 15 minutes, then every 15 min.

• Cuff pressure

• Pharyngolaryngeal discomfort 2 and 24 hours (telephone interview if released from hospital) after extubation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Scheduled elective surgery with general anesthesia and planned endotracheal intubation.

Exclusion Criteria:

• ASA=3,

• 20>BMI<35

• Allergy to local anesthetics or neuromuscular blocking agents.

• The ASA physical status classification system is a system for assessing the fitness of patients before surgery. BMI is Body Mass Index measured in kilograms/square meter.

Related Conditions & MeSH terms

• Intubation Complication
• Muscle Hypotonia
• Pharyngitis

Intervention

Drug:
• Lidocaine spray (2%)
Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes
• Muscle Relaxant (Rocuronium)
After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.

Other:
• No Muscle relaxant, no Lidocaine
This group get general anesthesia without Rocuronium or Lidocaine

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust, Moss	Grålum	Ostfold

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. Epub 2007 Jun 15. — View Citation

Domaoal AM, Weniger FC, Wolfson B. "Precurarization" using pancuronium. Anesth Analg. 1975 Jan-Feb;54(1):71-5. — View Citation

Doyle DJ. Airway anesthesia: theory and practice. Anesthesiol Clin. 2015 Jun;33(2):291-304. doi: 10.1016/j.anclin.2015.02.013. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD004081. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.)
Primary	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.)