Brief Article
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World J Gastrointest Endosc. May 16, 2013; 5(5): 231-239
Published online May 16, 2013. doi: 10.4253/wjge.v5.i5.231
Usefulness of applying lidocaine in esophagogastroduodenoscopy performed under sedation with propofol
Felipe de la Morena, Cecilio Santander, Carlos Esteban, Beatriz de Cuenca, Juan Antonio García, Javier Sánchez, Ricardo Moreno
Felipe de la Morena, Carlos Esteban, Beatriz de Cuenca, Endoscopy Unit, Department of Gastroenterology, Hospital Universitario Infanta Cristina, CP 28981 Parla, Madrid, Spain
Cecilio Santander, Ricardo Moreno, Department of Gastroenterology, Hospital Universitario de la Princesa, CP 28006 Madrid, Spain
Juan Antonio García, Department of Anaesthesiology, Hospital Universitario Infanta Cristina, CP 28981 Parla, Madrid, Spain
Javier Sánchez, Department of Pharmacology, Hospital Universitario Infanta Cristina, CP 28981 Parla, Madrid, Spain
Author contributions: de la Morena F performed all the esophagogastroduodenoscopies, designed the protocol, and wrote the manuscript; de Cuenca B, Santander C and Moreno R revised and approved the final manuscript for submission; Sánchez J provided pharmacological support, established and ensured blinding of the recruitment; García JA coordinated and administered the propofol sedation for all study participants; Esteban C participated in quality assessment of the statistical analyses.
Supported by Empresa Pública Hospital del Sur, Parla (Madrid) Spain
Correspondence to: Dr. Felipe de la Morena, Endoscopy Unit, Department of Gastroenterology, Hospital Universitario Infanta Cristina, Avenida 9 de Junio 2, CP 28981 Parla, Madrid, Spain. felipe_de_la_morena@hotmail.com
Telephone: +34-91-1913100 Fax: +34-91-1913950
Received: January 21, 2013
Revised: March 5, 2013
Accepted: April 10, 2013
Published online: May 16, 2013
Processing time: 113 Days and 13.4 Hours
Abstract

AIM: To determine whether topical lidocaine benefits esophagogastroduoduenoscopy (EGD) by decreasing propofol dose necessary for sedation or procedure-related complications.

METHODS: The study was designed as a prospective, single centre, double blind, randomised clinical trial and was conducted in 2012 between January and May (NCT01489891). Consecutive patients undergoing EGD were randomly assigned to receive supplemental topical lidocaine (L; 50 mg in an excipient solution which was applied as a spray to the oropharynx) or placebo (P; taste excipients solution without active substance, similarly delivered) prior to the standard propofol sedation procedure. The propofol was administered as a bolus intravenous (iv) dose, with patients in the L and P groups receiving initial doses based on the patient’s American Society of Anaesthesiologists (ASA) classification (ASA I-II: 0.50-0.60 mg/kg; ASA III-IV: 0.25-0.35 mg/kg), followed by 10-20 mg iv dose every 30-60 s at the anaesthetist’s discretion. Vital signs, anthropometric measurements, amount of propofol administered, sedation level reached, examination time, and the subjective assessments of the endoscopist’s and anaesthetist’s satisfaction (based upon a four point Likert scale) were recorded. All statistical tests were performed by the Stata statistical software suite (Release 11, 2009; StataCorp, LP, College Station, TX, United States).

RESULTS: No significant differences were found between the groups treated with lidocaine or placebo in terms of total propofol dose (310.7 ± 139.2 mg/kg per minute vs 280.1 ± 87.7 mg/kg per minute, P = 0.15) or intraprocedural propofol dose (135.3 ± 151.7 mg/kg per minute vs 122.7 ± 96.5 mg/kg per minute, P = 0.58). Only when the L and P groups were analysed with the particular subgroups of female, < 65-year-old, and lower anaesthetic risk level (ASA I-II) was a statistically significant difference found (L: 336.5 ± 141.2 mg/kg per minute vs P: 284.6 ± 91.2 mg/kg per minute, P = 0.03) for greater total propofol requirements). The total incidence of complications was also similar between the two groups, with the L group showing a complication rate of 32.2% (95%CI: 21.6-45.0) and the P group showing a complication rate of 26.7% (95%CI: 17.0-39.0). In addition, the use of lidocaine had no effect on the anaesthetist’s or endoscopist’s satisfaction with the procedure. Thus, the endoscopist’s satisfaction Likert assessments were equally distributed among the L and P groups: unsatisfactory, [L: 6.8% (95%CI: 2.2-15.5) vs P: 0% (95%CI: 0-4.8); neutral, L: 10.1% (95%CI: 4.2-19.9) vs P: 15% (95%CI: 7.6-25.7)]; satisfactory, [L: 25.4% (95%CI: 10-29.6) vs P: 18.3% (95%CI: 15.5-37.6); and very satisfactory, L: 57.6% (95%CI: 54-77.7) vs P: 66.6% (95%CI: 44.8-69.7)]. Likewise, the anaesthetist’s satisfaction Likert assessments regarding the ease of maintaining a patient at an optimum sedation level without agitation or modification of the projected sedation protocol were not affected by the application of lidocaine, as evidenced by the lack of significant differences between the scores for the placebo group: unsatisfactory, L: 5.8% (95%CI: 1.3-13.2) vs P: 0% (95%CI: 0-4.8); neutral, L: 16.9% (95%CI: 8.9-28.4) vs P: 16.7% (95%CI: 8.8-27.7); satisfactory, L: 15.2% (95%CI: 7.7-26.1) vs P: 20.3% (95%CI: 11.3-31.6); and very satisfactory, L: 62.7% (95%CI: 49.9-74.3) vs P: 63.3% (95%CI: 50.6-74.7).

CONCLUSION: Topical pharyngeal anaesthesia is safe in EGD but does not reduce the necessary dose of propofol or improve the anaesthetist’s or endoscopist’s satisfaction with the procedure.

Keywords: Lidocaine; Propofol; Esophagogastroduodenoscopy; Sedation; Adverse effects

Core tip: We are pleased to report the second study in the literature about the possible efficacy of using an adjuvant topical anaesthesia, in this case lidocaine applied as a spray to the oropharynx, during esophagogastroduodenoscopy performed under sedation with propofol. This study is unique, however, in that it is the first randomized controlled trial demonstrating that this routine application has no beneficial effect on reduction of propofol dose or procedure-related complications, or on improved satisfaction of the endoscopist or anaesthetist. These findings may help to improve and streamline the current procedures used for endoscopy sedation, saving resources such as time during surgery and monetary costs for the topical agent.