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

NCT03031808 | Unknown Phase 4 DMC

• 1 other identifier: AB3383
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (4)

• 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.)

Study Arms (3)

Lidocaine spray

OTHER

Endotracheal lidocaine spray prior to intubation

Drug: Lidocaine spray (2%)

Muscle relaxant

OTHER

Muscle relaxant prior to intubation

Drug: Muscle Relaxant (Rocuronium)

No Muscle relaxant, no Lidocaine

OTHER

'No Muscle relaxant, no Lidocaine Control group

Other: No Muscle relaxant, no Lidocaine

Interventions

Lidocaine spray (2%) DRUG

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

Also known as: Xylocain 2% Astra Zeneca

Lidocaine spray

Muscle Relaxant (Rocuronium) DRUG

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

Also known as: Esmeron MSD

Muscle relaxant

No Muscle relaxant, no Lidocaine OTHER

This group get general anesthesia without Rocuronium or Lidocaine

Also known as: Control group

No Muscle relaxant, no Lidocaine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ASA≥3,
• \>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.

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Ostfold Hospital Trust, Moss

Grålum, Østfold fylke, 1714, Norway

RECRUITING

Related 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.

  PMID: 26082898 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.

  PMID: 11094588 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.

  PMID: 17573390 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.

  PMID: 1167764 BACKGROUND

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

  PMID: 25999003 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.

  PMID: 25109156 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.

  PMID: 2890365 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.

  PMID: 10084094 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.

  PMID: 7741805 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.

  PMID: 23839320 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.

  PMID: 19588349 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.

  PMID: 8904261 BACKGROUND

MeSH Terms

Interventions

Rocuronium; Control Groups

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jan Sverre Vamnes, MD, Ph.D.

  Senior consultant

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, Ph.D.

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 26, 2017
• Study Start: October 31, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)