Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566326
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Oropharyngeoesophageal Topical Anesthesia Versus Propofol - Ketamine Sedation for Upper Gastrointestinal Endoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oropharyngeoesophageal Topical Anesthesia Prototype Device Versus Intravenous Propofol - Ketamine Sedation for Upper Gastrointestinal Endoscopy
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Esophagogastroduodenoscopy EGD is an essential and widely used diagnostic and therapeutic procedure in gastroenterology EGD can be performed in association with topical anesthesia of the pharynx intravenous anesthesia or with their combination Sedation is required to alleviate anxiety provide analgesia amnesia and to improve endoscopic performance specifically in therapeutic procedures However sedation-related gastrointestinal endoscopy complications when occur may lead to significant morbidity and occasional mortality especially with moderate and deep sedation Cardiopulmonary complications resulting from aspiration oversedation hypoventilation vasovagal reflex and airway obstruction account for more than 50 of all complications associated with upper endoscopy Topical pharyngeal anesthesia currently is a requirement for upper endoscopy to provide patients with the best comfort in unsedated EGD In Hong Kong 10 Xylocaine pump spray AstraZeneca Sodertalje Sweden is the pharyngeal anesthesia generally used as a premedication in unsedated EGD The aim of this study was to provide more effective safer tolerable and offers quicker recovery technique using either the modified Oropharyngeoesophageal Topical Anesthesia OPETA technique or conventional intravenous sedation by prepared mixture of propofol and ketamine ketofol 41
Detailed Description:
This Randomized prospective clinical study was conducted at Zagazig University Hospitals in anesthesia intensive care and pain management department at the outpatient endoscopy unit service at general medicine department on 60 patients scheduled to undergo elective upper GI endoscopy All upper GI endoscopy procedures was preformed by OLYMPUS EVIS EXERA III CV- 190 Written informed consent was obtained from all participants
According to a computer-generated randomization table patients were allocated to two equal groups 30 patients in each group Group PK Included 30 patients received intravenous sedation using prepared mixture of propofol and ketamine in the ratio 41
Group OPETA
Included 30 patients underwent modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool Nofal 2010
All participants were subjected to
Obtaining of history and physical examination including vital signs cardiac and chest condition as well as excluding criteria Routine laboratory investigations included Complete blood count CBC Random blood sugar coagulation profile PT PTT INR liver function tests renal function tests General and airway examination was done All patients were kept fasting for 4 hours from clear fluids and 6 hours from other foods Midazolam 2-25 mg IV was given to all patients at holding area
Study design
After routine pre-operative evaluation standard monitors were connected to the patients pulse oximetry noninvasive blood pressure and electrocardiogram and baseline parameter were recorded peripheral oxygen saturation mean arterial pressure and heart rate Intravenous IV line will be inserted and atropine IV 1 mg administered for all patients Patients will be allocated into two equal groups by a computer-generated randomization table
Group PK n30
Patients received intravenous sedation using prepared mixture of propofol and ketamine in ratio 41 It is prepared by mixing 08 mgkg propofol with 02 mgkg ketamine 41 in an IV bolus followed by half of the initial dose every 3 minutes as needed for sedation The desired level of sedation was achieved more than score 4 using Modified Ramsay sedation score before allowing endoscopiest to start the procedure then the score was assessed every 3 minutes before giving of top up doses of ketofol 41 half of the initial dose if needed then the range and median of modified Ramsay sedation score was calculated
Group OPETA n30
Every patient by him or herself or by help of anesthetist topicalized the anterior tonsillar pillar on both sides and the posterior one third of the tongue as well as the posterior pharyngeal wall using xylocain gel 5 on the tip of his index or middle finger then after 5-7 minutes the patient inserted his middle finger deeply into his mouth as a test for tolerability before the insertion of OPETA tool the patient was instructed not to swallow the used local anesthetic but gurgle it as long as possible While the head tilted forward chin on chest Lubricated Oropharyngeoseogageal pack OPETA device soaked with 10 ml lidocaine 2 mixed with adrenaline 1200000 was gradually placed by the patient himself or herself with assistance from the anesthetist and patients swallowing into the esophagus To ensure effective topical anesthesia and patient tolerance the pack was left in place for three to five minutes before being moved up down clockwise and anti-clockwise If necessary increments of 5 ml of 2 lidocaineadrenaline mixture was injected through the device until the patient is comfortable For all patients the maximum local anesthetic dose 5 mgkg of lidocaine without adrenaline and 7 mgkg of a lidocaine with adrenaline 1200000 was meticulously considered However we tryied to keep the maximum dosage at 5 mgkg as we dealing with topical anesthesia at the mucous membrane
The Oropharyngeo-esophygeal Topical Anesthesa OPETA device
It is a handmade device of a patented concept patency no 23733 academy of scientific research and technology ARST Egypt it is originally used as supraglottic topical anesthesia device The prototype OPETA device consists of orogastric tube surrounded by a cotton gauze of 5 cm width The tube and device size are age dependent and usually of 16-gauge tube size The tip of the orogastric tube is burnt eg by a flame of lighter and simultaneously clamped by a needle holder Air under pressure is then pushed through the tube port using a 10 ml syringe to verify integrity of the closed tip Starting from the burnt closed tip the orogastric tube was punctured with a 21-gauge needle in two perpendicular planes with 1 cm in between each puncture within the same plane for 45 to 50 cm in adult cases representing the length of a line passing from the mouth to earlobe then to xyphoid process 5 cm wide cotton gauze was wrapped over the punctured part of the tube and secured with 2- 0 Mersilk After inserting the device into the oropharyngeal cavity and esophagus local anesthetic LA adrenaline mixture was injected into the punctured tube when required The injected LA was sprayed through the puncture sites to the surrounding cotton gauze that is in contact with the oropharyngeal and esophageal mucosa anesthetizing it During the device insertion if it is required to make the device less malleable for easier insertion part of an ureteric guide wire or ureteric catheter cover could be inserted within the tube of the device to strengthen it After getting the patient sedated or topically anesthetized endoscopist started the procedure The modified Aldretes scoring system was used for the discharge of all patients from recovery Achievement of at least 9 out of 10 scores was the criteria for discharge in this study Twenty four hour after the procedure all patients were asked through telephone connection about their experiences regarding the intraprocedural events they were asked to score their satisfaction level during the procedure in terms of recalling any painful or other undesirable intraprocedural events
Monitoring
Standard monitors for all cases include patients heart rate oxygen saturation and MAP pre-procedural basal for both topical and sedation groups then every 5 minutes throughout the procedure until the patient is fully alert Side effects such as hypotension and bradycardia were recorded if hypotension occurs decrease in MAP more than 20 from baseline it was treated with normal saline and if blood pressure was not corrected ephedrine 5 mg was administered incrementally and if bradycardia occurs HR 60 beatsmin it was treated with atropine 001 mgkg
Post procedural assessment
1 Patient assessment
Two separate questionnaires were asked to the patients in order to rate the procedure 24 hours after discharge when they become completely alert through telephone connection The patients answered the following questions
The difficulty in insertion of OPETA device
Discomfort they felt during procedure Answers was given on a 0 -10-mm numeric rating scale The left end of the scale 0 mm will be defined as not at all and the right end 10 mm as extremely
2 Endoscopist assessment
The endoscopist assessed the following
1 Difficulty in introducing the endoscope
2 The overall technical difficulty of the examination
3 Gagging whether occurred or not For endoscopists assessment the 0-10 numeric rating scale was the measurement scale where 0 means the procedure was extremely comfortable and 10 means that it was extremely uncomfortable
Data collection
Patient characteristics Age Sex ASA physical status class BMI Indications of endoscopic procedure Baseline heart rate mean arterial blood pressure MAP and oxygen saturation were recorded every five minutes throughout endoscopic procedure and every 10 minutes when the patients at PACU Patient Assessment numeric rating scale 0 10
1 Discomfort felt during the procedure
2 Willing to Re-do in OPETA group Endoscopist Assessment numeric rating scale 0 10 1 Difficulty in introducing the endoscope 2 Gagging with esophageal intubation 3 The endoscopist satisfaction Number of doses in PK group
Time
1 OPETA time Time from administration of self or helped oral topical anesthesia till getting the OPETA device manipulation tolerated by the patient moving the OPETA tool up and down clockwise and anti-clockwise without distressing the patient
2 Sedation time Time from starting intravenous sedation until ability to insert endoscope freely
3 Endoscopy time Time from starting of insertion till removal of the endoscope
4 Recovery time Time since the endoscopist finish the endoscopy until the patient is completely alert and oriented to space and time
5 Discharge time Time from admission to the recovery area to get the patient ready for discharge from the recovery area using modified aldert score
6 Total time summation of previous times Any complications eg systemic toxicity respiratory depression desaturation nausea and vomiting in both studied groups were recorded and managed
According to a computer-generated randomization table patients were allocated to two equal groups 30 patients in each group Group PK Included 30 patients received intravenous sedation using prepared mixture of propofol and ketamine in the ratio 41
Group OPETA
Included 30 patients underwent modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool Nofal 2010
All participants were subjected to
Obtaining of history and physical examination including vital signs cardiac and chest condition as well as excluding criteria Routine laboratory investigations included Complete blood count CBC Random blood sugar coagulation profile PT PTT INR liver function tests renal function tests General and airway examination was done All patients were kept fasting for 4 hours from clear fluids and 6 hours from other foods Midazolam 2-25 mg IV was given to all patients at holding area
Study design
After routine pre-operative evaluation standard monitors were connected to the patients pulse oximetry noninvasive blood pressure and electrocardiogram and baseline parameter were recorded peripheral oxygen saturation mean arterial pressure and heart rate Intravenous IV line will be inserted and atropine IV 1 mg administered for all patients Patients will be allocated into two equal groups by a computer-generated randomization table
Group PK n30
Patients received intravenous sedation using prepared mixture of propofol and ketamine in ratio 41 It is prepared by mixing 08 mgkg propofol with 02 mgkg ketamine 41 in an IV bolus followed by half of the initial dose every 3 minutes as needed for sedation The desired level of sedation was achieved more than score 4 using Modified Ramsay sedation score before allowing endoscopiest to start the procedure then the score was assessed every 3 minutes before giving of top up doses of ketofol 41 half of the initial dose if needed then the range and median of modified Ramsay sedation score was calculated
Group OPETA n30
Every patient by him or herself or by help of anesthetist topicalized the anterior tonsillar pillar on both sides and the posterior one third of the tongue as well as the posterior pharyngeal wall using xylocain gel 5 on the tip of his index or middle finger then after 5-7 minutes the patient inserted his middle finger deeply into his mouth as a test for tolerability before the insertion of OPETA tool the patient was instructed not to swallow the used local anesthetic but gurgle it as long as possible While the head tilted forward chin on chest Lubricated Oropharyngeoseogageal pack OPETA device soaked with 10 ml lidocaine 2 mixed with adrenaline 1200000 was gradually placed by the patient himself or herself with assistance from the anesthetist and patients swallowing into the esophagus To ensure effective topical anesthesia and patient tolerance the pack was left in place for three to five minutes before being moved up down clockwise and anti-clockwise If necessary increments of 5 ml of 2 lidocaineadrenaline mixture was injected through the device until the patient is comfortable For all patients the maximum local anesthetic dose 5 mgkg of lidocaine without adrenaline and 7 mgkg of a lidocaine with adrenaline 1200000 was meticulously considered However we tryied to keep the maximum dosage at 5 mgkg as we dealing with topical anesthesia at the mucous membrane
The Oropharyngeo-esophygeal Topical Anesthesa OPETA device
It is a handmade device of a patented concept patency no 23733 academy of scientific research and technology ARST Egypt it is originally used as supraglottic topical anesthesia device The prototype OPETA device consists of orogastric tube surrounded by a cotton gauze of 5 cm width The tube and device size are age dependent and usually of 16-gauge tube size The tip of the orogastric tube is burnt eg by a flame of lighter and simultaneously clamped by a needle holder Air under pressure is then pushed through the tube port using a 10 ml syringe to verify integrity of the closed tip Starting from the burnt closed tip the orogastric tube was punctured with a 21-gauge needle in two perpendicular planes with 1 cm in between each puncture within the same plane for 45 to 50 cm in adult cases representing the length of a line passing from the mouth to earlobe then to xyphoid process 5 cm wide cotton gauze was wrapped over the punctured part of the tube and secured with 2- 0 Mersilk After inserting the device into the oropharyngeal cavity and esophagus local anesthetic LA adrenaline mixture was injected into the punctured tube when required The injected LA was sprayed through the puncture sites to the surrounding cotton gauze that is in contact with the oropharyngeal and esophageal mucosa anesthetizing it During the device insertion if it is required to make the device less malleable for easier insertion part of an ureteric guide wire or ureteric catheter cover could be inserted within the tube of the device to strengthen it After getting the patient sedated or topically anesthetized endoscopist started the procedure The modified Aldretes scoring system was used for the discharge of all patients from recovery Achievement of at least 9 out of 10 scores was the criteria for discharge in this study Twenty four hour after the procedure all patients were asked through telephone connection about their experiences regarding the intraprocedural events they were asked to score their satisfaction level during the procedure in terms of recalling any painful or other undesirable intraprocedural events
Monitoring
Standard monitors for all cases include patients heart rate oxygen saturation and MAP pre-procedural basal for both topical and sedation groups then every 5 minutes throughout the procedure until the patient is fully alert Side effects such as hypotension and bradycardia were recorded if hypotension occurs decrease in MAP more than 20 from baseline it was treated with normal saline and if blood pressure was not corrected ephedrine 5 mg was administered incrementally and if bradycardia occurs HR 60 beatsmin it was treated with atropine 001 mgkg
Post procedural assessment
1 Patient assessment
Two separate questionnaires were asked to the patients in order to rate the procedure 24 hours after discharge when they become completely alert through telephone connection The patients answered the following questions
The difficulty in insertion of OPETA device
Discomfort they felt during procedure Answers was given on a 0 -10-mm numeric rating scale The left end of the scale 0 mm will be defined as not at all and the right end 10 mm as extremely
2 Endoscopist assessment
The endoscopist assessed the following
1 Difficulty in introducing the endoscope
2 The overall technical difficulty of the examination
3 Gagging whether occurred or not For endoscopists assessment the 0-10 numeric rating scale was the measurement scale where 0 means the procedure was extremely comfortable and 10 means that it was extremely uncomfortable
Data collection
Patient characteristics Age Sex ASA physical status class BMI Indications of endoscopic procedure Baseline heart rate mean arterial blood pressure MAP and oxygen saturation were recorded every five minutes throughout endoscopic procedure and every 10 minutes when the patients at PACU Patient Assessment numeric rating scale 0 10
1 Discomfort felt during the procedure
2 Willing to Re-do in OPETA group Endoscopist Assessment numeric rating scale 0 10 1 Difficulty in introducing the endoscope 2 Gagging with esophageal intubation 3 The endoscopist satisfaction Number of doses in PK group
Time
1 OPETA time Time from administration of self or helped oral topical anesthesia till getting the OPETA device manipulation tolerated by the patient moving the OPETA tool up and down clockwise and anti-clockwise without distressing the patient
2 Sedation time Time from starting intravenous sedation until ability to insert endoscope freely
3 Endoscopy time Time from starting of insertion till removal of the endoscope
4 Recovery time Time since the endoscopist finish the endoscopy until the patient is completely alert and oriented to space and time
5 Discharge time Time from admission to the recovery area to get the patient ready for discharge from the recovery area using modified aldert score
6 Total time summation of previous times Any complications eg systemic toxicity respiratory depression desaturation nausea and vomiting in both studied groups were recorded and managed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None