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

NCT06566326 | 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. 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

Keywords

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.

  Endoscopy time: Time from starting of insertion till removal of the endoscope

Secondary Outcomes (3)

• Difficulty in insertion of OPETA device

  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).

• Difficulty in introducing the endoscope

  Endoscopy time: Time from starting of insertion till removal of the endoscope

• Overall technical difficulty of the examination

  Endoscopy time: Time from starting of insertion till removal of the endoscope

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

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 DRUG

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.

Also known as: Intravenous sedation

Group (PK)

Modified Oropharyngeo-esophygeal Topical Anesthesia by OPETA Prototype tool DEVICE

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.

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

Related Publications (7)

• Amornyotin, S. (2015). Anesthesia innovations for endoscopy of gastrointestinal tract. Endoscopy-innovative uses and emerging technologies. Croatia: InTech, 39-61.

  BACKGROUND

• de la Morena F, Santander C, Esteban C, de Cuenca B, Garcia JA, Sanchez J, Moreno R. Usefulness of applying lidocaine in esophagogastroduodenoscopy performed under sedation with propofol. World J Gastrointest Endosc. 2013 May 16;5(5):231-9. doi: 10.4253/wjge.v5.i5.231.

  PMID: 23678376 BACKGROUND

• hfeda, M. A. M., Ganaw, A., Ahmed, S. M. G., Chanda, A., Mahood, Z., Jabira, S., et al . (2021). Anaesthetic Considerations in Gastrointestinal Endoscopies. In Esophagitis and Gastritis-Recent Updates. (Edited by Vincenzo Neri and Monjur Ahmed) Ch 9, P. 141- 158. BoD- Book on Demand .

  BACKGROUND

• Feng AY, Kaye AD, Kaye RJ, Belani K, Urman RD. Novel propofol derivatives and implications for anesthesia practice. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):9-15. doi: 10.4103/0970-9185.202205.

  PMID: 28413268 BACKGROUND

• Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.

  PMID: 22000794 BACKGROUND

• Kamalipour, H., Joghataei, P., & Kamali, K. (2009). Comparing the Combination Effect of Propofol-Ketamine and Propofol-Alfentanil on Hemodynamic Stability during Induction of General Anesthesia in the Elderly.

  BACKGROUND

• Nofal O. Awake light-aided blind nasal intubation: prototype device. Br J Anaesth. 2010 Feb;104(2):254-9. doi: 10.1093/bja/aep367. Epub 2009 Dec 26.

  PMID: 20037149 BACKGROUND

MeSH Terms

Interventions

Propofol; Ketamine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Osama A Nofal, MD

  Zagazig University

  STUDY DIRECTOR

• Rania A Kamel, MD

  Zagazig University

  STUDY CHAIR

• Badiea B Elhag, Msc

  Zagazig University

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Zagazig University

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 30, 2023
• Last Updated: August 30, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)