Effect of Laryngoscopy and Tracheal IntubationPhase 4NCT03456947
Pregabalin Stabilize Cardiovascular Response to Intubation
A Phase 4 study testing Pregabalin in people with Effect of Laryngoscopy and Tracheal Intubation, run by Shanghai Zhongshan Hospital.
Trial summary
The purpose of the study is to evaluate whether Pregabalin is safe and effective in stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Effect of Laryngoscopy and Tracheal Intubation
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Jun 2017
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists(ASA) grade I and II scheduled for elective surgery
Who cannot join
- patient refusal.
- patients with serious chronic kidney, liver, lungs, or cardiovascular diseases.
- allergy to any of the study medications.
- patients taking sedation or antihypertensive medications.
- suspected difficult intubation or intubation time more than 22s.
- pregnant or breastfeeding women.
- BMI>30.
About this study
Official title: Research of Pregabalin Stabilize Cardiovascular Response to Laryngoscopy and Tracheal Intubation of Patients Under General Anesthesia
The purpose of the study is to evaluate whether Pregabalin is safe and effective in stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under general anesthesia.
- Being tested
- Pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | the patients receive routine preoperative preparation without having Pregabalin |
| Pregabalin150mg group | Experimental | the patients receive 150mg pregabalin 60 minutes prior to the surgery Receives: Drug: Pregabalin |
| Pregabalin300mg group | Experimental | the patients receive 300mg pregabalin 60 minutes prior to the surgery Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the heart rate due to laryngoscopy and tracheal intubation
Measured: heart rate 3 minutes after intubation
Secondary outcomes (5)
Mean arterial blood pressure
effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the Mean arterial blood pressure due to laryngoscopy and tracheal intubation
Measured: baseline mean arterial blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
systolic blood pressure
effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the systolic blood pressure due to laryngoscopy and tracheal intubation
Measured: baseline systolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
diastolic blood pressure
effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the diastolic blood pressure due to laryngoscopy and tracheal intubation
Measured: baseline diastolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
Ramsay score
Ramsay score of 300mg pregabalin, 150mg pregabalin premedication versus
Measured: baseline Ramsay score before drug administration and Ramsay score before intubation
Incidence of all clinical adverse events
The occurrence of dizziness, nausea, vomit and allergy
Measured: 1hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Laryngoscopy and Tracheal IntubationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Chen, Principal investigator, Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456947
- Sponsor's protocol ID
- CWW-PRBL-2017
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen W, Huang H, Yang C, Hu X, Bao F, Jiang H. Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China. Clin Ther. 2019 Jan;41(1):68-77. doi: 10.1016/j.clinthera.2018.11.006. Epub 2018 Dec 13.
PubMed 30553555
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Pregabalin Stabilize Cardiovascular Response to Laryngoscopy and Tracheal Intubation of Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03456947
- Acronym / sponsor ID
- CWW-PRBL-2017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 7 Mar 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 purpose of the study is to evaluate whether Pregabalin is safe and effective in stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –the patients receive routine preoperative preparation without having Pregabalin |
| Pregabalin150mg group | Experimental | Drug: Pregabalinthe patients receive 150mg pregabalin 60 minutes prior to the surgery |
| Pregabalin300mg group | Experimental | Drug: Pregabalinthe patients receive 300mg pregabalin 60 minutes prior to the surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists(ASA) grade I and II scheduled for elective surgery
Key exclusion criteria (7 listed)
- patient refusal.
- patients with serious chronic kidney, liver, lungs, or cardiovascular diseases.
- allergy to any of the study medications.
- patients taking sedation or antihypertensive medications.
- suspected difficult intubation or intubation time more than 22s.
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 |
|---|---|---|
| Pregabalinthe patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery | Drug | Pregabalin150mg group, Pregabalin300mg group |
Primary outcome
heart rate
Time frame: heart rate 3 minutes after intubation
effect of 300mg pregabalin, 150mg pregabalin premedication versus control group on the heart rate due to laryngoscopy and tracheal intubation
5 secondary outcomes
Mean arterial blood pressure
Time frame: baseline mean arterial blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
systolic blood pressure
Time frame: baseline systolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
diastolic blood pressure
Time frame: baseline diastolic blood pressure before drug administration, heart rate before intubation, heart rate after 0 minute, 1minute, 3minutes, 5 minutes, 7minutes, 10minutes after intubation and before skin incision
Ramsay score
Time frame: baseline Ramsay score before drug administration and Ramsay score before intubation
Incidence of all clinical adverse events
Time frame: 1hour after surgery
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 9 Mar 2018.
- Derived from this study: PubMed 30553555Chen W, Huang H, Yang C, Hu X, Bao F, Jiang H. Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China. Clin Ther. 2019 Jan;41(1):68-77. doi: 10.1016/j.clinthera.2018.11.006. Epub 2018 Dec 13.
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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.
Wei Chen principal investigator
Zhongshan Hospital Qinpu Branch, Fudan University, Shanghai
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Effect of Laryngoscopy and Tracheal Intubation, run by Shanghai Zhongshan Hospital.
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 7 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 9 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
heart rate (time frame: heart rate 3 minutes after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03456947, which also lists 1 linked publication.
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 9 Mar 2018.