Topical Bupivacaine Effect On The Response To Awake Extubation During Emergence From General Anesthesia

NCT04471597 | Completed

• 1 other identifier: 6201//12-7-2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

• Emergence from general anesthesia is often complicated by the ETT-induced emergence phenomena (EP), which include coughing, sympathetic stimulation, sore throat, increased bleeding from the surgical site, and increased intracranial and intraocular pressures.
• Techniques that have been used to help diminish coughing during emergence include "deep" extubation (removal of the endotracheal tube \[ETT\] while the patient is still in a deep plane of general anesthesia), administration of intravenous (IV) narcotics, or administration of IV lidocaine prior to emergence since systemic narcotics and lidocaine have antitussive properties. However, each of these techniques has limitations. A reliable technique for improving ETT tolerance while facilitating rapid and full emergence from general anesthesia would be desirable in many situations.
• Topical application of bupivacaine to the pharyngeal, laryngeal, and tracheal mucosa will attenuate or even abolish coughing as well as a hemodynamic response during extubation, thus result in increasing the patient's comfort and avoiding potential complications of extubation process.
• Up to the investigator's knowledge there is no study done to evaluate the effect of topical bupivacaine on the incidence of coughing and hemodynamic response during emergence from general anesthesia in patients undergoing elective thyroidectomy.

Conditions

Thyroid Diseases

Keywords

topical bupivacaine; awake extubation; thyroidectomy; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Grade of coughing

  will be assessed as Grade 0: no cough; Grade 1: single cough with mild severity; Grade 2: cough lasting less than 5 s with moderate severity; Grade 3: sustained bouts of persistent cough more than 5 s.

  procedure (measured within the extubation time)

Secondary Outcomes (5)

• oxygen saturation(SpO2)

  will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.

• heart rate

  will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.

• mean arterial blood pressure

  will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.

• Extubation time

  Procedure -from the end of the anesthesia (discontinuation of isoflurane) to the time the endotracheal tube will be pulled out

• Sore throat degree

  1 , 2 , 4, 6 and 12 hours postoperatively.

Study Arms (2)

Control group

PLACEBO COMPARATOR

patients will receive 5ml of normal saline 0.9% topically 15 min before the expected end of surgery.

Drug: normal saline 0.9%

bupivacaine group

ACTIVE COMPARATOR

patients will receive 5ml of bupivacaine 0.5% topically 15 min before the expected end of surgery.

Drug: Bupivacaine Hydrochloride

Interventions

normal saline 0.9% DRUG

5ml of normal saline 0.9% topically 15 min will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and the patient will be mechanically ventilated as usual.

Control group

Bupivacaine Hydrochloride DRUG

5 ml of bupivacaine 0.5% will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and patient will be mechanically ventilated as usual.

bupivacaine group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance. BMI \< 35kg/m2. ASA I and ASA II. Scheduled for elective thyroidectomy under general anesthesia

You may not qualify if:

• Patient refusal. History or anticipated difficult intubation. Chronic respiratory disease such as chronic obstructive pulmonary disease or asthma.
• Recent respiratory tract infection in the last month, chronic cough, and current smoking.
• History of laryngeal or tracheal surgery or pathology. Patients with symptomatic gastric reflux. Patients with a known history of allergy to study drugs.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (6)

• Shabnum T, Ali Z, Naqash IA, Mir AH, Azhar K, Zahoor SA, Mir AW. Effects of Lignocaine Administered Intravenously or Intratracheally on Airway and Hemodynamic Responses during Emergence and Extubation in Patients Undergoing Elective Craniotomies in Supine Position. Anesth Essays Res. 2017 Jan-Mar;11(1):216-222. doi: 10.4103/0259-1162.200239.

  PMID: 28298788 BACKGROUND

• Meng YF, Cui GX, Gao W, Li ZW. Local airway anesthesia attenuates hemodynamic responses to intubation and extubation in hypertensive surgical patients. Med Sci Monit. 2014 Aug 26;20:1518-24. doi: 10.12659/MSM.890703.

  PMID: 25175842 BACKGROUND

• Fang P, Zong Z, Lu Y, Han X, Liu X. Effect of topical ropivacaine on the response to endotracheal tube during emergence from general anesthesia: a prospective randomized double-blind controlled study. BMC Anesthesiol. 2018 Sep 27;18(1):134. doi: 10.1186/s12871-018-0601-x.

  PMID: 30261837 BACKGROUND

• Phero JC, Prithvi Raj P, Knarr D, Turner P, Denson DD, Vigdorth E, Edstrom HH. Absorption of bupivacaine after topical application to the oropharynx. Anesth Prog. 1987 Sep-Oct;34(5):187-90.

  PMID: 3479919 BACKGROUND

• Mogensen S, Sverrisdottir E, Sveinsdottir K, Treldal C, Jensen K, Jensen AB, Kristensen CA, Jacobsen J, Kreilgaard M, Petersen J, Andersen O. Absorption of Bupivacaine after Administration of a Lozenge as Topical Treatment for Pain from Oral Mucositis. Basic Clin Pharmacol Toxicol. 2017 Jan;120(1):71-78. doi: 10.1111/bcpt.12644. Epub 2016 Sep 26.

  PMID: 27430990 BACKGROUND

• Fisman EZ, Shapira I, Motro M, Pines A, Tenenbaum A. The combined cough frequency/severity scoring: a new approach to cough evaluation in clinical settings. J Med. 2001;32(3-4):181-7.

  PMID: 11563816 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Saline Solution; Bupivacaine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blinded ( patient and outcome assessors)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, lecturer

Model Details: The patients will be divided randomly by a computer-generated randomization table into two equal groups

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 15, 2020
• Study Start: July 20, 2020
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)