Conscious Sedation Failure During Procedure
Conditions
Keywords
oral midazolam, sedation, premedication, upper gastrointestinal endoscopy, EGD
Brief summary
Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?
Detailed description
Five mg of midazolam was intake orally about 30 minutes before undergoing perform upper gastrointestinal endoscopy. Declined of anxiety scores was primary end point.
Interventions
DRUGOral midazolam
5 mg in 15 mL of apple juice, orally 30 minutes before undergoing EGD
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo elective diagnostic EGD * American Society of Anesthesia (ASA) criteria to be class 1 to 2
Exclusion criteria
* History of gastrectomy, esophagectomy, pancreaticoduodenectomy, or other operation on the upper-GI tract * American Society of Anesthesia (ASA) criteria to be class 3 to 4 * Pregnancy * Alcoholism * Drug abuse * Taking psychotic medications * Allergy to midazolam.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of Anxiety score | Asked the patient 5 minutes before EGD and then after fully recovery from sedation. | * Anxiety score is 10-cm scaled visual analog scale. * Anxiety score which asked the patient 5 minutes before EGD, called Pre EGD anxiety score * Anxiety score which asked the patient after fully recovery, called During EGD anxiety score. * Difference of anxiety score means Pre EGD minus During anxiety score. * Fully recovery means fully gain of consiouness (time, place, person). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall tolerance | Asked the patient after fully recovery from sedation. | Fully recovery means fully gain of consiouness (time, place, person). Overall tolerance was grading into 4 levels; * Poor : Very uncomfortable during the entire procedure * Fair : Uncomfortable during most of the procedure * Good : Believes the procedure was generally comfortable, there were portions of procedure during which sedation could have been given * Excellent : Believes the procedure was comfortable, no additional sedation was needed |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall satisfaction | Asked the patient after fully recovery from sedation. | Fully recovery means fully gain of consiouness (time, place, person). Overall satifaction was 10-cm scaled visual analog scale. |
| Amnesia score | Asked the patient after fully recovery from sedation. | Fully recovery means fully gain of consiouness (time, place, person). Amnesia score was grading into 4 levels; 1. = Patient unable to recall any portion of procedure 2. = Able to recall and describe some portion of procedure 3. = Able to recall and describe most of procedure 4. = Able to recall and describe entire procedure |
| Willing to repeat EGD | Asked the patient after fully recovery from sedation. | Fully recovery means fully gain of consiouness (time, place, person). Willing to repeat EGD was defined to Yes or No. |
| Vital signs | Vital signs were measured at 5 minutes before EGD then measured every 5 minutes during EGD until the patient was fully recovery after the EGD was finished. | Vital signs were blood pressure(mmHg), heart rates(beats per minute), respiratory rates(per minute) and oxygen saturation(percents). |
Countries
Thailand
Contacts
Primary ContactChaipichit Puttapitakpong, Doctor
Outcome results
None listed