Gastrointestinal Endoscopy, Moderate Sedation, Propofol, Target Controlled Infusion
Conditions
Brief summary
Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).
Detailed description
70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).
Interventions
Sponsors
Ospedale San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 yrs * ASA (American Society of Anesthesiologists risk class III-IV)I-II * patients undergoing to gastroscopy or colonoscopy
Exclusion criteria
* significant systemic disease (American Society of Anesthesiologists risk class III-IV) * history of allergic reactions to any of the study drugs * chronic use of opioid analgesics * psychiatric disorder * pregnancy * difficult airways (Mallampati score \>2) * age \<18 yrs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation | one day | Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100). |
| Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation | one day | Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (number of partecipants with adverse events) of propofol TCI moderate sedation | one day | To compare safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists. |
| Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients | one day | To compare time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients in group standard versus propofol TCI group safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists. |
Countries
Italy
Outcome results
None listed