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Comparative Study of the Effects of Adding Ketamine or Lidocaine to Propofol and Fentanyl on Gag Reflex During Upper Gastrointestinal Endoscopy: A Randomised Controlled Trial

Comparative Study of the Effects of Adding Ketamine or Lidocaine to Propofol and Fentanyl on Gag Reflex During Upper Gastrointestinal Endoscopy: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250923004
Enrollment
708
Registered
2025-09-23
Start date
2025-09-22
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGD Esophagogastroduodenoscopy Colonoscopy Gag reflex Ketamine Lidocaine EGD Esophagogastroduodenoscopy Colonoscopy Gag reflex Adults Lidocaine Ketamine

Interventions

Participants in this group will receive standard induction with propofol 2-2.5mg/kg IV via TCI, and fentanyl 50 mcg IV (or 25 mcg if aged more than or equal to 65 years and/or weighing equal or less t
Control,Lidocaine,Ketamine

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 Adult patients aged between 18 and 75 years old 2 Undergoing elective EGD with or without colonoscopy

Exclusion criteria

Exclusion criteria: 1 Patient refusal to participate 2 Known allergy or contraindication to ketamine, or fentanyl 3 ASA physical status classification of greater than III 4 Patients with respiratory, haemodynamic, or neurologic impairment, identified by signs of respiratory distress, SBP less than 90 mmHg or SBP/DBP of more than 160/90, or a Glasgow Coma 5 Score less than 15 6 Patients with a body weight less than or equal to 40kg 7 Patients with body mass index (BMI) more than 30 kg/m2 8 Patients with cognitive impairment, communication limitations and/or lack of decision-making capacity 9 Pregnant or lactating women 10 Patients with severe gastrointestinal disorders (e.g., active GI bleeding, recent GI surgery) or those with with a full stomach, ascites, or inadequate NPO time 11 Patients with active psychosis 12 Patients with a suspected or confirmed current or past history of narcotic abuse or potential for secondary gain 13 Patients who require intubation

Design outcomes

Primary

MeasureTime frame
Cough and gag reflex Intraoperative Cough and gag reflex will be assessed by the endoscopists using the Cough and Gag Score when a vomiting-like response is elicited upon insertion of the endoscope

Secondary

MeasureTime frame
Complications, recovery time, Ramsey Sedation score, Surgeon and Patient satisfaction score Intra-operative and immediately post-operative in PACU at 5, 10, 15 and 20 minutes post-op Complications will be documented and Ramsey sedation score as well as patient and surgeon satisfaction score will be done via a Likert scale

Countries

Thailand

Contacts

Public ContactPhornnapat Utenpattanun

Khon Kaen University

pat.uten@gmail.com043363060

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026