Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation

NCT06756594 | Completed

• 1 other identifier: Soh-Med-24-11-02MS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare efficacy of sedation between Dexmedetomidine-Propofol and Ketamine-Propofol combinations in the upper or lower gastrointestinal system endoscopy. We compare between 2 combinations as regard hemodynamic stability, post operative side effects as occurrence of delirium, nausea, vomiting, headache, hallucination or agitation.

Conditions

Propofol

Outcome Measures

Primary Outcomes (1)

• intraoperative and postoperative monitoring of sedation during upper or lower gastrointestinal system endoscopy.

  Sedation level

  every 5 minutes intraoperative and every 15 minutes for 2 hours postoperative.

Study Arms (2)

Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy

ACTIVE COMPARATOR

efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy.

Drug: Dexmedetomidine-Propofol

Ketamine-Propofol for sedation during gastrointestinal endoscopy

ACTIVE COMPARATOR

efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy.

Drug: Ketamine-Propofol

Interventions

Dexmedetomidine-Propofol DRUG

efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy.

Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy

Ketamine-Propofol DRUG

efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy.

Ketamine-Propofol for sedation during gastrointestinal endoscopy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status I to II.
• Age between 18 and 60 years.
• Both sexes.

You may not qualify if:

• Having severe heart, lung, liver disease, kidney failure, or bleeding disorder.
• Patients having fever, hypothermia or infection, electrolyte disorders, such as hypokalemia and hypocalcaemia, acid-base disorder, allergy to drugs to be used.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

• Tekeli AE, Oguz AK, Tuncdemir YE, Almali N. Comparison of dexmedetomidine-propofol and ketamine-propofol administration during sedation-guided upper gastrointestinal system endoscopy. Medicine (Baltimore). 2020 Dec 4;99(49):e23317. doi: 10.1097/MD.0000000000023317.

  PMID: 33285707 BACKGROUND

• Zhang F, Sun HR, Zheng ZB, Liao R, Liu J. Dexmedetomidine versus midazolam for sedation during endoscopy: A meta-analysis. Exp Ther Med. 2016 Jun;11(6):2519-2524. doi: 10.3892/etm.2016.3186. Epub 2016 Mar 24.

  PMID: 27284342 BACKGROUND

• Chang ET, Certal V, Song SA, Zaghi S, Carrasco-Llatas M, Torre C, Capasso R, Camacho M. Dexmedetomidine versus propofol during drug-induced sleep endoscopy and sedation: a systematic review. Sleep Breath. 2017 Sep;21(3):727-735. doi: 10.1007/s11325-017-1465-x. Epub 2017 Jan 27.

  PMID: 28130737 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: November 12, 2024
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

EG (1)