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

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

July 1, 2023

Study Completion Date

July 30, 2023

Conditions
Upper Gastrointestinal EndoscopyTopical AnesthesiaIntravenous 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.

Trial Locations (1)

44111

Zagazig university hospitals, Zagazig

All Listed Sponsors
lead

Zagazig University

OTHER_GOV