Gastrointestinal EndoscopyNCT03632330
Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis
An observational study of Gastrointestinal Endoscopy and Sedation, run by Pfizer at 1 site in South Korea.
Trial summary
The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Gastrointestinal Endoscopy, Sedation, Dexmedetomidine
- What is being tested?
- Dexmedetomidine, Midazolam and Propofol
- How many people
- 6,963 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Feb 2018to 7 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Two reviewers independently extract data, including outcomes of interests, demographics of the enrolled patients' population, inclusion and exclusion criteria for each study, the comparative drug used, the number of patients in each group, sedation target and posology.
- Inclusion criteria We will include studies if they (1) the setting was using any sedative for endoscopy for an procedural sedation (2) the study compared dexmedetomidine with other sedative for sedative therapy and (3) the outcomes included satisfaction score and adverse events.
- Exclusion criteria We excluded studies if they (1) the number of sedative was different in two arms (2) did not report the specific results comparing dexmedetomidine with other sedatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS
The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.
Read the detailed description
A variety of sedatives are available in procedural sedation and the efficacy \& safety have been compared in several trials for procedural sedation. However, none of clinical trial has enough number of patients to clarify the conclusive differences among sedatives. Thus, pooling all available studies together systematically by network meta-analysis for GI endoscopic procedure may provide a better understanding of efficacy and safety of sedatives. Therefore we would like to conduct a network meta-analysis to analyze the outcomes of GI endoscopy by using the most recently-published interventional trials.
- Conditions
- Gastrointestinal Endoscopy, Sedation, Dexmedetomidine
- Being tested
- Dexmedetomidine, Midazolam, Propofol, Midazolam/Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called The group includes patients treated with Dexmedetomidine
Dexmedetomidine group
MidazolamDrug
Also called The group includes patients treated with Midazolam
Midazolam group
PropofolDrug
Also called The group includes patients treated with Propofol
Propofol group
Midazolam/PropofolDrug
Also called The group includes patients treated with Midazolam and propofol
Midazolam/Propofol group
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Dexmedetomidine group Receives: Drug: Dexmedetomidine | |
| Midazolam | Midazolam group Receives: Drug: Midazolam | |
| propofol | propofol group Receives: Drug: Propofol | |
| Midazolam/Propofol | Midazolam and Propofol group Receives: Drug: Midazolam/Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who experience desaturation
SaO2 < 94% for more than 10 seconds, RR<8, apneic episodes, face mask
Measured: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure.
Secondary outcomes (2)
Number of subjects who experience Hypotension
BP<90/50, decrease>20% or 10mmHg, MAP<60mmHg or MAP decrease>20%
Measured: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Number of subjects who experience Bradycardia
A heart rate of <50 beats per min, decrease > 15%
Measured: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start5 Feb 2018
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 6,963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632330
- Sponsor's protocol ID
- C0801043
- Status last verified
- Jul 2019
- First submitted
- 30 Jul 2018
- Last updated
- 6 Apr 2023
- Results posted
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS
- ClinicalTrials.gov ID
- NCT03632330
- Acronym / sponsor ID
- C0801043
- Conditions
- Gastrointestinal Endoscopy, Sedation, Dexmedetomidine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,963 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.
Detailed description
A variety of sedatives are available in procedural sedation and the efficacy \& safety have been compared in several trials for procedural sedation. However, none of clinical trial has enough number of patients to clarify the conclusive differences among sedatives. Thus, pooling all available studies together systematically by network meta-analysis for GI endoscopic procedure may provide a better understanding of efficacy and safety of sedatives. Therefore we would like to conduct a network meta-analysis to analyze the outcomes of GI endoscopy by using the most recently-published interventional trials.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | – | Drug: DexmedetomidineDexmedetomidine group |
| Midazolam | – | Drug: MidazolamMidazolam group |
| propofol | – | Drug: Propofolpropofol group |
| Midazolam/Propofol | – | Drug: Midazolam/PropofolMidazolam and Propofol group |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two reviewers independently extract data, including outcomes of interests, demographics of the enrolled patients' population, inclusion and exclusion criteria for each study, the comparative drug used, the number of patients in each group, sedation target and posology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: The group includes patients treated with DexmedetomidineDexmedetomidine group | Drug | Dexmedetomidine |
| MidazolamAlso: The group includes patients treated with MidazolamMidazolam group | Drug | Midazolam |
| PropofolAlso: The group includes patients treated with PropofolPropofol group | Drug | propofol |
| Midazolam/PropofolAlso: The group includes patients treated with Midazolam and propofolMidazolam/Propofol group | Drug | Midazolam/Propofol |
Primary outcome
Number of subjects who experience desaturation
Time frame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure.
SaO2 < 94% for more than 10 seconds, RR<8, apneic episodes, face mask
2 secondary outcomes
Number of subjects who experience Hypotension
Time frame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Number of subjects who experience Bradycardia
Time frame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Endoscopy and Sedation, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who experience desaturation (time frame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.