search
Back to results

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

Primary Purpose

Thyroid Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
normal saline 0.9%
Bupivacaine Hydrochloride
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Diseases focused on measuring topical bupivacaine, awake extubation, thyroidectomy, general anesthesia

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

  • Faculty of medicine, zagazig university

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

bupivacaine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

oxygen saturation(SpO2)
heart rate
Hemodynamics
mean arterial blood pressure
Hemodynamics
Extubation time
removal of the endotracheal tube [ETT] while the patient is still in a deep plane of general anesthesia
Sore throat degree
will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative sore throat pain where 0= No pain and 10= Maximum worst pain.

Full Information

First Posted
July 12, 2020
Last Updated
October 6, 2023
Sponsor
Zagazig University
search

1. Study Identification

Unique Protocol Identification Number
NCT04471597
Brief Title
Topical Bupivacaine Effect On The Response To Awake Extubation During Emergence From General Anesthesia
Official Title
Topical Bupivacaine Effect On The Response To Awake Extubation During Emergence From General Anesthesia In Patients Undergoing Elective Thyroidectomy. A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The process of manipulation of the airway during laryngoscopy, endotracheal intubation, and extubation is usually associated with exaggerated hemodynamic response including tachycardia, hypertension as well as increase intraocular and intracranial pressure[1,2]. The exact mechanism to these hemodynamic responses may be due to the release of catecholamine in the blood by stimulating the sympathetic nervous system during these stressful periods. Acute hemodynamic changes during extubation may lead to life-threatening myocardial ischemia, arrhythmias, pulmonary edema, acute heart failure, or cerebrovascular hemorrhage in high-risk patients and this can increase morbidity and mortality of the patients [3]. Respiratory complications after tracheal extubation are three times more common than induction of anesthesia and intubation [4], as intratracheal tube induces laryngeal irritation that transmitted through rapidly acting receptors which are located throughout the trachea, involved in the cough reflex and subsequently lead to coughing and bucking that frequently occur during extubation and may lead to negative pressure pulmonary edema as well as, laryngeal edema and sore throat [5, 6]. Various techniques have been applied to attenuate the hemodynamic responses and coughing during emergence and extubation. They include deep extubation, administration of intravenous (IV) short-acting narcotics, calcium channel blockers, and dexmedetomidine [7,8], as well as lidocaine which is considered one of the commonly used drugs either through IV route, endotracheal tube (ETT) cuff, or laryngotracheal route[1,9]. Concern about the use of these drugs includes respiratory depression, delayed emergence from anesthesia, postoperative nausea and vomiting, sedative effects, and short action time [10]. Bupivacaine is a kind of sodium channel blocker local anesthetics used as topical anesthesia that suppresses cough by inhibiting the progression of the action potential in the tracheal touch-sensitive Aδ fibers (cough receptors)[10]. The plasma protein binding of bupivacaine exceeds 90%, whereas lidocaine protein binding is 65- 75%, [11] and it is well known that the duration of local anesthetics is influenced by their protein binding characteristics, as the affinity for plasma proteins corresponds to the affinity for protein binding at the sodium channel receptor site, that results in prolongation of the presence of the anesthetic effect at the site of action [12, 13]. the investigators hypothesize that usage of topical bupivacaine may have an impact on decreasing incidence of coughing and alleviating hemodynamic response during awake extubation and emergence from general anesthesia in post-thyroidectomy patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases
Keywords
topical bupivacaine, awake extubation, thyroidectomy, general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be divided randomly by a computer-generated randomization table into two equal groups
Masking
ParticipantOutcomes Assessor
Masking Description
double-blinded ( patient and outcome assessors)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients will receive 5ml of normal saline 0.9% topically 15 min before the expected end of surgery.
Arm Title
bupivacaine group
Arm Type
Active Comparator
Arm Description
patients will receive 5ml of bupivacaine 0.5% topically 15 min before the expected end of surgery.
Intervention Type
Drug
Intervention Name(s)
normal saline 0.9%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Grade of coughing
Description
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.
Time Frame
procedure (measured within the extubation time)
Secondary Outcome Measure Information:
Title
oxygen saturation(SpO2)
Time Frame
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.
Title
heart rate
Description
Hemodynamics
Time Frame
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.
Title
mean arterial blood pressure
Description
Hemodynamics
Time Frame
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.
Title
Extubation time
Description
removal of the endotracheal tube [ETT] while the patient is still in a deep plane of general anesthesia
Time Frame
Procedure -from the end of the anesthesia (discontinuation of isoflurane) to the time the endotracheal tube will be pulled out
Title
Sore throat degree
Description
will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative sore throat pain where 0= No pain and 10= Maximum worst pain.
Time Frame
1 , 2 , 4, 6 and 12 hours postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient acceptance. BMI < 35kg/m2. ASA I and ASA II. Scheduled for elective thyroidectomy under general anesthesia Exclusion Criteria: 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.
Facility Information:
Facility Name
Faculty of medicine, zagazig university
City
Zagazig
State/Province
Elsharqya
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
planned after the completion of the study and publication
IPD Sharing Time Frame
planned after the completion of the study and publication
IPD Sharing Access Criteria
principal investigator
Citations:
PubMed Identifier
28298788
Citation
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.
Results Reference
background
PubMed Identifier
25175842
Citation
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.
Results Reference
background
PubMed Identifier
30261837
Citation
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.
Results Reference
background
PubMed Identifier
3479919
Citation
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.
Results Reference
background
PubMed Identifier
27430990
Citation
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.
Results Reference
background
PubMed Identifier
11563816
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs