Endoscopic Ultrasound (EUS), Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conditions
Keywords
EUS, ERCP, Sedation Level, Adverse Symptoms, Recovery time
Brief summary
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.
Detailed description
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.
Interventions
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.
Exclusion criteria
* History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine. * Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent. * Patients with conditions that preclude safe conscious sedation will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Percentage of Sedation Failures | From onset of sedation to completion of procedure, approximately 1 hour. | The percentage of participants who could not complete the procedure due inability to achieve proper sedation level |
| Time to Achieve Adequate Level of Sedation to Begin Procedure | Pre-Endoscopic Procedure (up to 1 hour maximum) | — |
| Time for Recovery | Post-Endoscopic Procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Symptoms From Sedative Agents | Approximately 3 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1- Saline Control Group Control. These patients will receive Normal Saline Injections to serve as controls.
Saline: Saline solution injections | 57 |
| 2 - Diphenhydramine Sedation Group These patients will receive Diphenhydramine injections given as adjunct sedative.
Diphenhydramine: Diphenhydramine injections | 58 |
| 3 - Promethazine Sedation Group Promethazine given as an adjunct sedative.
Promethazine: Promethazine | 60 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 44 | 44 | 41 |
Baseline characteristics
| Characteristic | 1- Saline Control Group | 2 - Diphenhydramine Sedation Group | 3 - Promethazine Sedation Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 28 Participants | 30 Participants | 85 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 3 | 56 years STANDARD_DEVIATION 3 | 58 years STANDARD_DEVIATION 3 | 57 years STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 26 Participants | 78 Participants |
| Sex: Female, Male Male | 31 Participants | 32 Participants | 34 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 57 | 0 / 60 |
| serious Total, serious adverse events | 0 / 58 | 0 / 57 | 0 / 60 |
Outcome results
Primary
Average Percentage of Sedation Failures
The percentage of participants who could not complete the procedure due inability to achieve proper sedation level
Time frame: From onset of sedation to completion of procedure, approximately 1 hour.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Control Arm: Normal Saline Injections. | Average Percentage of Sedation Failures | 14 percentage of participants | Standard Deviation 2 |
| 2 - Diphenhydramine Injections Given as Adjunct Sedative. | Average Percentage of Sedation Failures | 13 percentage of participants | Standard Deviation 2 |
| 3 - Promethazine Given as an Adjunct Sedative. | Average Percentage of Sedation Failures | 5 percentage of participants | Standard Deviation 1 |
Primary
Time for Recovery
Time frame: Post-Endoscopic Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Control Arm: Normal Saline Injections. | Time for Recovery | 21.3 minutes | Standard Deviation 5 |
| 2 - Diphenhydramine Injections Given as Adjunct Sedative. | Time for Recovery | 29.5 minutes | Standard Deviation 4 |
| 3 - Promethazine Given as an Adjunct Sedative. | Time for Recovery | 51.5 minutes | Standard Deviation 6 |
Primary
Time to Achieve Adequate Level of Sedation to Begin Procedure
Time frame: Pre-Endoscopic Procedure (up to 1 hour maximum)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Control Arm: Normal Saline Injections. | Time to Achieve Adequate Level of Sedation to Begin Procedure | 15 minutes | Standard Deviation 3 |
| 2 - Diphenhydramine Injections Given as Adjunct Sedative. | Time to Achieve Adequate Level of Sedation to Begin Procedure | 13 minutes | Standard Deviation 4 |
| 3 - Promethazine Given as an Adjunct Sedative. | Time to Achieve Adequate Level of Sedation to Begin Procedure | 14 minutes | Standard Deviation 5 |
Secondary
Adverse Symptoms From Sedative Agents
Time frame: Approximately 3 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Control Arm: Normal Saline Injections. | Adverse Symptoms From Sedative Agents | 0 adverse events | Standard Deviation 0 |
| 2 - Diphenhydramine Injections Given as Adjunct Sedative. | Adverse Symptoms From Sedative Agents | 0 adverse events | Standard Deviation 0 |
| 3 - Promethazine Given as an Adjunct Sedative. | Adverse Symptoms From Sedative Agents | 0 adverse events | Standard Deviation 0 |