Effects of Dexmedetomidine on Sedation during Gastrointestinal Endoscopy
The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study
This study is testing whether different doses of a medication called dexmedetomidine can make sedation safer and more effective for people having advanced upper gastrointestinal endoscopy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Theodor Bilharz Research Institute Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Trial ID | NCT06414395 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of different loading doses of dexmedetomidine on the effectiveness of propofol sedation in patients undergoing advanced upper gastrointestinal endoscopic procedures. The study aims to find the optimal balance between dexmedetomidine and propofol to enhance sedation safety and efficacy. Participants will receive either dexmedetomidine or a saline infusion while their sedation levels are monitored using the bispectral index. The goal is to improve patient outcomes by minimizing complications associated with traditional sedation methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with ASA I-II physical status and a BMI under 35.
Not a fit: Patients with ASA III-IV status, high aspiration risk, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective sedation protocols for patients undergoing gastrointestinal endoscopic procedures.
How similar studies have performed: Previous studies have shown promising results with dexmedetomidine in sedation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-65 * Both sexes * ASA I-II * BMI \<35 Exclusion Criteria: * Patients' refusal to participate * ASA III-IV * BMI \> 35 * Patients who are considered high aspiration risk, e.g., gastric outlet obstruction * Allergy to any medications used * Diabetics * Any patient receiving cardioactive drugs, e.g., Beta blockers, Calcium channel blockers, Inhaled B2 bronchodilators) * Patients with Pacemakers or heart rate below 50 beat/min * Pregnant women * Habitual Drug abusers * Patients who had to be intubated during the procedure.
Where this trial is running
Cairo, Giza Governorate
- Theodor Bilharz Research Institute — Cairo, Giza Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Sameh M. Elaidy, Msc.
- Email: sameh.elaidy@hotmail.com
- Phone: 1111776906
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.