Oropharyngeoesophageal Topical Anesthesia Versus Intravenous Propofol -Ketamine Sedation for Upper Gastrointestinal Endoscopy

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.With regard to the most common sedation regimen used in different countries. In the United States, more than 75% of endoscopists use a benzodiazepine plus narcotic combination, with the combination of midazolam and fentanyl being the most common. A significant percentage of endoscopists (43%) also use propofol regularly, mainly in a hospital setting. In Germany, the most frequently used agents are midazolam (82%) and propofol (74%), and the most common sedation regimens used are propofol plus benzodiazepines (38%) and benzodiazepines plus an opioid (35%). With regard to usage of topical anesthesia during upper gastrointestinal endoscopy, in the United Kingdom it was reported that 63% of endoscopists used topical anesthesia regularly during performance of upper gastrointestinal endoscopy. While twenty percent did not use pharyngeal anesthesia at all, and 17% used pharyngeal anesthesia sometimes. 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. Many studies have compared topical anesthetic agents to other formulations and techniques such as viscous, lozenge, lollipop, and nebulized lidocaine administration. However, it is still unclear which technique is optimal in terms of its influence on the gag reflex, patient tolerability, and pain. Serious allergic reactions were considered to be a risk of local anesthesia in earlier publications, but these are extremely rare. More attention is being paid to the risk of overdosing because lignocaine, the most widely used substance, is a respiratory depressant and an overdose can result in convulsion, hypotension, bradycardia, and even cardiac arrest. As the spray is rapidly absorbed by mucous membranes, the dose should be limited to 200 mg in adults (20 sprays), and in children the limit is 10 sprays. However British Thoracic Society recommends an upper limit of 8.2 mg/kg. The aim of the study is providing 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 4:1) .

Conditions

• Upper Gastrointestinal Endoscopy
• Topical Anesthesia
• Intravenous Sedation

Interventions

DRUG

Propofol and Ketamine Mixture (Ketofol)

Included 30 patients received intravenous sedation using prepared mixture of propofol and ketamine (in the ratio 4:1).It is prepared by mixing 0.8 mg/kg propofol with 0.2 mg/kg ketamine (4:1) 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 4:1 (half of the initial dose) if needed, then the range and median of modified Ramsay sedation score was calculated.

DEVICE

Modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool

Topicalization was done for the anterior tonsillar pillar on both sides and the posterior 1/3 of tongue and posterior pharyngeal wall using xylocain gel 5 % on tip of his index or middle finger then after 5-7 min, patient inserted his middle finger deeply into his mouth as a test for tolerability before insertion of OPETA tool. While the head tilted forward, Lubricated OPETA device, soaked with 10 ml lidocaine 2 % mixed with adrenaline 1/200000 was gradually placed by the patient with assistance from the anesthetist and patients swallowing into the esophagus. To ensure effective topical anesthesia and patient tolerance, pack was left in place for 3-5 min before being moved up, down, clockwise and anti-clockwise. If necessary, increments of 5 ml of 2% lidocaine/adrenaline mixture was injected through the device until the patient is comfortable. The maximum local anesthetic dose was kept at 5 mg/kg.

Sponsors & Collaborators

• Zagazig University

  lead OTHER_GOV

Principal Investigators

• Mona Shahin, MD · Zagazig University

• Osama Nofal, MD · Zagazig University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2023-05-30

Completion

2023-06-01

Countries

• Egypt

Study Locations