Endoscopy, Sedation
Conditions
Brief summary
Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.
Interventions
DRUGPropofol
70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
DRUGMidazolam
70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged \< 70, 0.03 mg/Kg if aged \> 70.
Sponsors
Università Vita-Salute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \< 18 years * American Society of Anesthesiologists risk I-II * patients undergoing to Gastroscopy or Colonoscopy
Exclusion criteria
* significant systemic disease * allergic reactions to any of study drugs * chronic use of opioids or psychiatric disorders * pregnancy * Mallampati score \> 2 * age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist's Satisfaction (Visual Analog Scale) About Sedation | at the end of the exam | Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist |
| Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge | before discharge | When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction) |
| Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure | at 24-72 hours after procedure | Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time (Minutes) to Dischargeability of Patient From Endoscopic Unit | one day | After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching. |
| Number of Participants With Adverse Events as a Measure of Safety | one day | Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...) |
Countries
Italy
Participant flow
Recruitment details
140 consecutive outpatients were scheduled to undergo Upper Endoscopy (70 patients) or complete Colonoscopy (70 patients) from 17 th February 2014 to 5 th May 2014 in Endoscopy Unit of San Raffaele Hospital - Milan.
Pre-assignment details
Exclusion criteria were: significant systemic disease (ASA III-IV), allergic reactions to study drugs, chronic use of opioids, psychiatric disorders, pregnancy, difficult airways (Mallampati score \>2), age \<18 years. A gastroenterology attending fellow (GF), not directly involved in the procedure, provided sedation.
Participants by arm
| Arm | Count |
|---|---|
| Propofol Group 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient's body weight and general condition.
35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.
Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient's arm covering the i.v. line and TCI pump). | 70 |
| Midazolam Group 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged \<70 years - 0.03 mg/kg if aged \>70 years).
35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Propofol Group | Midazolam Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 13 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 57 Participants | 112 Participants |
| Region of Enrollment Italy | 70 participants | 70 participants | 140 participants |
| Sex: Female, Male Female | 30 Participants | 32 Participants | 62 Participants |
| Sex: Female, Male Male | 40 Participants | 38 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist
Time frame: at the end of the exam
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propofol Group; n=35, 35 | Endoscopist's Satisfaction (Visual Analog Scale) About Sedation | upper endoscopy | 93 units on a scale | Standard Deviation 14 |
| Propofol Group; n=35, 35 | Endoscopist's Satisfaction (Visual Analog Scale) About Sedation | colonoscopy | 98 units on a scale | Standard Deviation 11 |
| Midazolam Group; n=35, 35 | Endoscopist's Satisfaction (Visual Analog Scale) About Sedation | upper endoscopy | 83 units on a scale | Standard Deviation 21 |
| Midazolam Group; n=35, 35 | Endoscopist's Satisfaction (Visual Analog Scale) About Sedation | colonoscopy | 87 units on a scale | Standard Deviation 12 |
Primary
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)
Time frame: at 24-72 hours after procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propofol Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure | Upper endoscopy | 93 units on a scale | Standard Deviation 20 |
| Propofol Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure | Colonoscopy | 97 units on a scale | Standard Deviation 9 |
| Midazolam Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure | Upper endoscopy | 77 units on a scale | Standard Deviation 27 |
| Midazolam Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure | Colonoscopy | 88 units on a scale | Standard Deviation 16 |
Primary
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)
Time frame: before discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Propofol Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge | Upper endoscopy | 94 units on a scale | Standard Deviation 18 |
| Propofol Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge | Colonoscopy | 95 units on a scale | Standard Deviation 9 |
| Midazolam Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge | Upper endoscopy | 76 units on a scale | Standard Deviation 25 |
| Midazolam Group; n=35, 35 | Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge | Colonoscopy | 85 units on a scale | Standard Deviation 14 |
Secondary
Number of Participants With Adverse Events as a Measure of Safety
Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)
Time frame: one day
Secondary
Time (Minutes) to Dischargeability of Patient From Endoscopic Unit
After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.
Time frame: one day