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

NCT ID: NCT03031808

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2020-12-31

Brief 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.

Detailed 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

Conditions

Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine spray

Endotracheal lidocaine spray prior to intubation

Group Type: OTHER

Lidocaine spray (2%)

Intervention Type: DRUG

Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes

Muscle relaxant

Muscle relaxant prior to intubation

Group Type: OTHER

Muscle Relaxant (Rocuronium)

Intervention Type: DRUG

After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.

No Muscle relaxant, no Lidocaine

'No Muscle relaxant, no Lidocaine Control group

Group Type: OTHER

No Muscle relaxant, no Lidocaine

Intervention Type: OTHER

This group get general anesthesia without Rocuronium or Lidocaine

Interventions

Lidocaine spray (2%)

Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes

Intervention Type: DRUG

Muscle Relaxant (Rocuronium)

After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.

Intervention Type: DRUG

No Muscle relaxant, no Lidocaine

This group get general anesthesia without Rocuronium or Lidocaine

Intervention Type: OTHER

Other Intervention Names

Xylocain 2% Astra Zeneca; Esmeron MSD; Control group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Jan Sverre Vamnes

Senior consultant, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Sverre Vamnes, MD, Ph.D.

Role: STUDY_CHAIR

Senior consultant

Locations

Ostfold Hospital Trust, Moss

Grålum, Østfold fylke, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jan Sverre Vamnes, MD, Ph.D

Role: CONTACT

jan.sverre.vamnes@so-hf.no

+47 913 05 016

Knut Inge Solbakk, MD

Role: CONTACT

knut.inge.solbakk@so-hf.no

+47 909 33 106

Facility Contacts

Jan Sverre Vamnes, MD, Ph.D.

Role: primary

janvam@so-hf.no

+47 91608896

Knut Inge Solbakk, md

Role: backup

knisol@so-hf.no

+47 90933106

References

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.

Reference Type: BACKGROUND

PMID: 26082898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11094588 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17573390 (View on PubMed)

Domaoal AM, Weniger FC, Wolfson B. "Precurarization" using pancuronium. Anesth Analg. 1975 Jan-Feb;54(1):71-5. doi: 10.1213/00000539-197501000-00014.

Reference Type: BACKGROUND

PMID: 1167764 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 25999003 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25109156 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2890365 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10084094 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7741805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23839320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19588349 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8904261 (View on PubMed)

Other Identifiers

AB3383

Identifier Type: -

Identifier Source: org_study_id