Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
Conditions
Keywords
Endoscopic submucosal dissection, propofol, remifentanil, dexmedetomidine, efficacy, safeness
Brief summary
Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.
Interventions
DRUGDexmedetomidine - remifentanil group
DRUGPropofol - remifentanil group
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥20 * American Society of Anaesthesiologists(ASA) physical status classification I\ III * Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection
Exclusion criteria
* Age \< 20 * American Society of Anaesthesiologists(ASA) physical status classification IV * those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure) * known drug allergies or history of drug abuse * psychological disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil | right after the drugs had administered | Safety : whether the complications as follows occur or not 1. systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP 2. heart rate under 50bpm 3. oxygen saturation under 90%, respiratory rate under 7 per minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil | right after the drugs had administered | Efficacy : 1. whether a bolus injection of 10 mg of propofol was administered or not 2. evaluating the depth of sedation using MOAA/S scale all through the procedure 3. whether the en bloc resection, complete resection were done or not under the sedation |
Other
| Measure | Time frame | Description |
|---|---|---|
| A comparison of patient's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil | within 24hrs after procedure | Patients' satisfaction : investigate in four steps questionaire (very good, good, bearable and unbearable) when the patients' were discharged from PACU |
| A comparison of gastric motility, easiness for procedure, operator's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil | right after the drugs had administered | Subjects' motility grading during procedure, easiness of procedure, operator's satisfaction : investigate in four steps questionaires by the operator after the procedure |
Countries
South Korea
Outcome results
None listed