Hemodynamic StabilityEarly Phase 1NCT05298761
Efficacy of I/v Nalbuphine v/s Iv Lignocain in Attanuation of Pressor Responseduring Laryngeoscopy and Intubation in Middle Age Patient Planned for Thyroid Surgery
A Early Phase 1 study testing Lignocaine in people with Hemodynamic Stability, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial summary
Comparison of I/V nalbuphine versus I/V xylocain in attanuation of pressor response during intubation and laryngeoscopy in patients undergoing for thyroid surgery,selection of better supressor agent minimises the drug repated side effects like hypertention tachycardia but also helps in heamodynamically stability at… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hemodynamic Stability
- What is being tested?
- Lignocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Dec 2023to 1 Jun 2024
- Phase
- Early Phase 1
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- middle age(18_40)
- Asa 1 and 2
- Non hypertensive
- Thyroid patients
- patient who gives consent
Who cannot join
- hypertensive
- Asa 3 and 4
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr.amna
Rahim Yar Khan, Punjab Province, 092
Dr.amna Sarwar, Fcps, 03218337129, Dr.amnasabir@gmail.com
About this study
Official title: Efficacy of IV Lignocaine Versus IV Nalbuphine for Attenuation of Pressor Response Diring Laryngoscopy and Intubation in Patients Planned for Thyroid Surgery
Comparison of I/V nalbuphine versus I/V xylocain in attanuation of pressor response during intubation and laryngeoscopy in patients undergoing for thyroid surgery,selection of better supressor agent minimises the drug repated side effects like hypertention tachycardia but also helps in heamodynamically stability at induction.
- Conditions
- Hemodynamic Stability
- Being tested
- Lignocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
Also called Nalbuphine
Inj lignocain and inj nalbuphine given to two groups of participants and effects of both drugs
| Study group | Role | What they receive |
|---|---|---|
| Lignocain | Experimental | I/V lignocain 1.5mg per kg given to participants in state dose Receives: Drug: Lignocaine |
| nalbuphine | Experimental | I/v nalbuphine 0.1mg per kg given to participants in stat dose Receives: Drug: Lignocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce stress response during intubation and hemodynamic stabilty
Assesment of Hemodynamic stability by observing vital signs
Measured: 10 minutes
Achieve hemodynamic stabilty and smooth intubation
Assesment of hemodynamic stability by clinical examination of vital signs
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start30 Dec 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic StabilityStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amna Sarwar, Sheikh Zayed Medical College
- Investigators
- Dr.amna Sarwar, Fcps, Principal investigator, Sheikh zaied medical hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298761
- Sponsor's protocol ID
- ASarwar
- Status last verified
- Nov 2023
- First submitted
- 22 Feb 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of IV Lignocaine Versus IV Nalbuphine for Attenuation of Pressor Response Diring Laryngoscopy and Intubation in Patients Planned for Thyroid Surgery
- ClinicalTrials.gov ID
- NCT05298761
- Acronym / sponsor ID
- ASarwar
- Conditions
- Hemodynamic Stability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 28 Mar 2022 (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.
Comparison of I/V nalbuphine versus I/V xylocain in attanuation of pressor response during intubation and laryngeoscopy in patients undergoing for thyroid surgery,selection of better supressor agent minimises the drug repated side effects like hypertention tachycardia but also helps in heamodynamically stability at induction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lignocain | Experimental | Drug: LignocaineI/V lignocain 1.5mg per kg given to participants in state dose |
| nalbuphine | Experimental | Drug: LignocaineI/v nalbuphine 0.1mg per kg given to participants in stat dose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- middle age(18_40)
- Asa 1 and 2
- Non hypertensive
- Thyroid patients
- patient who gives consent
Key exclusion criteria (3 listed)
- hypertensive
- Asa 3 and 4
- Patient refusal
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 |
|---|---|---|
| LignocaineAlso: NalbuphineInj lignocain and inj nalbuphine given to two groups of participants and effects of both drugs | Drug | Lignocain, nalbuphine |
Primary outcome
Reduce stress response during intubation and hemodynamic stabilty
Time frame: 10 minutes
Assesment of Hemodynamic stability by observing vital signs
Achieve hemodynamic stabilty and smooth intubation
Time frame: 10 minutes
Assesment of hemodynamic stability by clinical examination of vital signs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Dr.amna Sarwar, Fcps principal investigator
Sheikh zaied medical hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lignocaine in people with Hemodynamic Stability, run by Sheikh Zayed Medical College 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 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 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.amna Sarwar, Fcps (03218337129, Dr.amnasabir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce stress response during intubation and hemodynamic stabilty (time frame: 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 21 Nov 2023.