Hemodynamic Stability Post Intubation in Laryngoscopy SurgeryPhase 3NCT03787069
Intravenous Lignocaine vs Placebo
A Phase 3 study of Hemodynamic Stability Post Intubation in Laryngoscopy Surgery, run by Indus Hospital and Health Network at 1 site in Pakistan.
Trial summary
To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Stability Post Intubation in Laryngoscopy Surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2017to 20 Jul 2018
- Phase
- Phase 3
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II
- Age 20-60 years
- Mallampatti , II
- All surgeries are done under GA
- Both genders
- Those patients giving informed consent
Who cannot join
- Difficult airway assessed during pre-op anaesthesia assessment
- Unanticipated difficult airway based on the previous history of difficult intubation
- BMI >30,
- Micrognathia and microglossia based on pre-op anaesthesia assessment,
- Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome
- Patients who do not give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation
To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery
Read the detailed description
After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.
- Being tested
- iv Lignocaine vs placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iv Lignocaine vs placeboDrug
Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V
| Study group | Role | What they receive |
|---|---|---|
| Lignocaine group | Experimental | This group will be given 1.5 mg/kg I/V lignocaine before intubation Receives: Drug: iv Lignocaine vs placebo |
| Placebo | Placebo comparator | This group will be given 6 ml normal saline before intubation Receives: Drug: iv Lignocaine vs placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP
mean arterial pressure
Measured: post-intubation 3 minutes to 10 minutes
Pulse
Heart rate
Measured: post-intubation 3 minutes to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start20 Dec 2017
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic Stability Post Intubation in Laryngoscopy SurgeryStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Equal allocation
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787069
- Sponsor's protocol ID
- IRD_IRB_2017_07_002
- Status last verified
- Dec 2018
- First submitted
- 24 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation
- ClinicalTrials.gov ID
- NCT03787069
- Acronym / sponsor ID
- IRD_IRB_2017_07_002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 26 Dec 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.
To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery
Detailed description
After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Equal allocation
| Arm | Type | Receives |
|---|---|---|
| Lignocaine group | Experimental | Drug: iv Lignocaine vs placeboThis group will be given 1.5 mg/kg I/V lignocaine before intubation |
| Placebo | Placebo comparator | Drug: iv Lignocaine vs placeboThis group will be given 6 ml normal saline before intubation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ASA I and II
- Age 20-60 years
- Mallampatti , II
- All surgeries are done under GA
- Both genders
Key exclusion criteria (6 listed)
- Difficult airway assessed during pre-op anaesthesia assessment
- Unanticipated difficult airway based on the previous history of difficult intubation
- BMI >30,
- Micrognathia and microglossia based on pre-op anaesthesia assessment,
- Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome
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 |
|---|---|---|
| iv Lignocaine vs placeboLignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V | Drug | Lignocaine group, Placebo |
Primary outcome
MAP
Time frame: post-intubation 3 minutes to 10 minutes
mean arterial pressure
Pulse
Time frame: post-intubation 3 minutes to 10 minutes
Heart rate
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 26 Dec 2018.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hemodynamic Stability Post Intubation in Laryngoscopy Surgery, run by Indus Hospital and Health Network at 1 site in Pakistan.
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 6 inclusion and 6 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 26 Dec 2018. 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 Pakistan. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
MAP (time frame: post-intubation 3 minutes to 10 minutes). The study lists 2 primary outcomes in all. 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 26 Dec 2018.