Oropharyngeoesophageal Topical Anesthesia Versus 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. 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 4:1) .

Conditions

• Upper Gastrointestinal Endoscopy
• Topical Anesthesia
• Intravenous Sedation

Interventions

DRUG

Propofol and ketamine

Patients received IV sedation using prepared mixture of propofol and ketamine in 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 anterior tonsillar pillar on both sides and 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 head tilted forward, Lubricated OPETA device, soaked with 10 ml lidocaine 2 % mixed with adrenaline 1/200000 was gradually placed by patient with assistance from anesthetist \& patients swallowing into esophagus. To ensure effective topical anesthesia and patient tolerance, pack was left in place for 3-5 min. before being moved up, down, clockwise \& anti-clockwise.. If necessary, increments of 5 ml of 2% lidocaine/adrenaline mixture was injected through device until patient is comfortable. Maximum LA dose was kept at 5 mg/kg.

Sponsors & Collaborators

• Zagazig University

  lead OTHER_GOV

Principal Investigators

• Osama A Nofal, MD · Zagazig University

• Rania A Kamel, MD · Zagazig University

• Badiea B Elhag, Msc · 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

2023-07-01

Completion

2023-07-30

Countries

• Egypt

Study Locations