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

NCT07563062 | Completed

• 1 other identifier: ZU-IRB#10002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.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; Intravenous Sedation; Topical Anesthesia

Keywords

Modified Oropharyngeo-esophygeal Topical Anesthesia; upper gastrointestinal endoscopy; Propofol-Ketamine sedation

Outcome Measures

Primary Outcomes (1)

• Patient discomfort felt during endoscopy

  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.

  24 hour after the procedure

Secondary Outcomes (4)

• Mean arterial pressure (MAP)

  0 min ,5 min, 10 min, 15 min, 20 min, 25min, 30 min throughout endoscopic procedure and 0 min, 10 min, 20 min, 30 min when the patients at PACU.

• Heart rate

  0 min ,5 min, 10 min, 15 min, 20 min, 25min, 30 min throughout endoscopic procedure and 0 min, 10 min, 20 min, 30 min when the patients at PACU.

• Oxygen saturation

  0 min ,5 min, 10 min, 15 min, 20 min, 25min, 30 min throughout endoscopic procedure and 0 min, 10 min, 20 min, 30 min when the patients at PACU.

• The endoscopist satisfaction

  immediately after the procedure

Study Arms (2)

Group (PK)

ACTIVE COMPARATOR

Patients received intravenous sedation using prepared mixture of propofol and ketamine (in the ratio 4:1)

Drug: Propofol and Ketamine Mixture (Ketofol)

Group (OPETA)

ACTIVE COMPARATOR

Patients underwent modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool

Device: Modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool

Interventions

Propofol and Ketamine Mixture (Ketofol) DRUG

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.

Group (PK)

Modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool DEVICE

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.

Group (OPETA)

Eligibility Criteria

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

You may qualify if:

• Both sexes.
• Patients aged between 21-64 years old undergoing elective upper GI endoscopy after taking informed consent.
• ASA class II /III
• BMI \< 30kg/m2

You may not qualify if:

• Hypersensitivity to drugs included in the study.
• Difficult airway or known airway problems.
• Active bleeding from esophageal varices.
• Emergency procedure
• Low base line oxygen saturation \< 92% at room air.
• Cases expected to need general anesthesia for the procedure as judged by endoscopist.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospitals

Zagazig, Sharqia Province, 44111, Egypt

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start: January 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: June 1, 2023
• Last Updated: May 1, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)