Conscious SedationNCT03387644
Pregabalin Premedication for Conscious Sedation
A study testing Pregabalin (PG) in people with Conscious Sedation, run by Menoufia University.
Trial summary
Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Pregabalin (PG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2015to 16 May 2017
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 21 and 65 years old American Society of Anaesthesiologists physical status II or III scheduled for elective flexible bronchoscopy
Who cannot join
- Patients with known allergy to any drug used in the study, chronic use of analgesics and/or sedatives, substance abuse, sleep apnea, renal or hepatic dysfunction, and psychiatric disorders.
About this study
Official title: Pregabalin Premedication for Conscious Sedation for Flexible Bronchoscopy: A Randomized Double Blind Controlled Study
Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and midazolam.
Read the detailed description
Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two equal groups, 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients sedated to achieve optimum working conditions. Intra-operative respiratory rate and post procedure patients' and pulmonologists' satisfaction were compared in both groups.
- Conditions
- Conscious Sedation
- Being tested
- Pregabalin (PG), Control placebo (C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin (PG)Drug
Also called Pregabalin for premedication
Pregabalin 150 mg one hour before the procedure as premedication.
Control placebo (C)Drug
Also called Placebo for premeditation
Placebo tablets one hour before the procedure as premedication.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin (PG) | Active comparator | Patients received 150 mg pregabalin one hour before the procedure. Receives: Drug: Pregabalin (PG) |
| Control placebo (C) | Placebo comparator | Patients received placebo tablet one hour before surgery. Receives: Drug: Control placebo (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of sedative
The total amount of the sedative used during the procedure.
Measured: 45 minutes during the procedure
Secondary outcomes (1)
Patients' satisfaction
Patient's satisfaction score was recorded using a score ranging from 0 not satisfied and 5 totally satisfied. The score was done using a questioner designed by the researchers.
Measured: 30 minutes after the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start15 Apr 2015
- Primary completion24 Nov 2016
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ezzeldin Ibrahim, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387644
- Sponsor's protocol ID
- MenoufiaU2015/5
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin Premedication for Conscious Sedation for Flexible Bronchoscopy: A Randomized Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT03387644
- Acronym / sponsor ID
- MenoufiaU2015/5
- Conditions
- Conscious Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 24 Nov 2016 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 2 Jan 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.
Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and midazolam.
Detailed description
Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two equal groups, 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients sedated to achieve optimum working conditions. Intra-operative respiratory rate and post procedure patients' and pulmonologists' satisfaction were compared in both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin (PG) | Active comparator | Drug: Pregabalin (PG)Patients received 150 mg pregabalin one hour before the procedure. |
| Control placebo (C) | Placebo comparator | Drug: Control placebo (C)Patients received placebo tablet one hour before surgery. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 21 and 65 years old American Society of Anaesthesiologists physical status II or III scheduled for elective flexible bronchoscopy
Key exclusion criteria (1 listed)
- Patients with known allergy to any drug used in the study, chronic use of analgesics and/or sedatives, substance abuse, sleep apnea, renal or hepatic dysfunction, and psychiatric disorders.
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 |
|---|---|---|
| Pregabalin (PG)Also: Pregabalin for premedicationPregabalin 150 mg one hour before the procedure as premedication. | Drug | Pregabalin (PG) |
| Control placebo (C)Also: Placebo for premeditationPlacebo tablets one hour before the procedure as premedication. | Drug | Control placebo (C) |
Primary outcome
Total amount of sedative
Time frame: 45 minutes during the procedure
The total amount of the sedative used during the procedure.
1 secondary outcome
Patients' satisfaction
Time frame: 30 minutes after the end of 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 2 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin (PG) in people with Conscious Sedation, run by Menoufia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Total amount of sedative (time frame: 45 minutes during 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 2 Jan 2018.