Intubation ComplicationPhase 1/2NCT06065956
Comparison of Hemodynamic Changes With Morphine Versus Esmolol During Induction of Anaesthesia
A Phase 1/2 study testing Intravenous morphine in people with Intubation Complication, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
Trial summary
Comparing hemodynamic changes with morphine versus esmolol as an adjuvant agent during induction of Anaesthesia Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Intravenous morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Aug 2022to 15 Jul 2023
- Phase
- Phase 1/2
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 2 patients presenting for elective surgery.
Who cannot join
- Patients having major cardiac disease.
- Metastatic disease.
- Pregnant females.
- Those unwilling to be part of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hemodynamic Changes With Morphine Versus Esmolol as an Adjuvant Agent During Induction of Anaesthesia
Comparing hemodynamic changes with morphine versus esmolol as an adjuvant agent during induction of Anaesthesia
Read the detailed description
Comparing hemodynamic profile of patients during induction of General Anesthesia with intravenous morphine as an adjuvant drug versus Intravenous esmolol as an adjuvant agent,My aim is to study which drug has superior hemodynamic profile in terms of hemodynamic stability of patient requiring General Anesthesia.
- Conditions
- Intubation Complication
- Being tested
- Intravenous morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous morphineDrug
Also called Intravenous esmolol
Morphine group(an opioid), participants were given intravenous morphine(an opioid) at induction of General Anaesthesia before laryngoscopy and intubation.
The other group,Esmolol group(cardioselective beta blocker), participants were given intravenous esmolol(cardioselective beta blocker) during induction of General Anesthesia before laryngoscopy and intubation.
| Study group | Role | What they receive |
|---|---|---|
| Morphine group | Experimental | Half of participants will be comprising of morphine group Receives: Drug: Intravenous morphine |
| Esmolol group | Experimental | Half of participants will be comprising of esmolol group Receives: Drug: Intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Change in blood pressure between baseline value and post Intubation value will be measured in millimeter of mercury (mmHg).
Measured: 06 months
Pulse rate
Change in pulse rate between baseline value and post intubation value will be measured per minute.
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start28 Aug 2022
- Primary completion15 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Navy Station Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenan Anwar Khan, Pakistan Navy Station Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065956
- Sponsor's protocol ID
- 433/8/22
- Status last verified
- Oct 2023
- First submitted
- 29 Aug 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Changes With Morphine Versus Esmolol as an Adjuvant Agent During Induction of Anaesthesia
- ClinicalTrials.gov ID
- NCT06065956
- Acronym / sponsor ID
- 433/8/22
- Conditions
- Intubation Complication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Pakistan Navy Station Shifa HospitalUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 4 Oct 2023 (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.
Comparing hemodynamic changes with morphine versus esmolol as an adjuvant agent during induction of Anaesthesia
Detailed description
Comparing hemodynamic profile of patients during induction of General Anesthesia with intravenous morphine as an adjuvant drug versus Intravenous esmolol as an adjuvant agent,My aim is to study which drug has superior hemodynamic profile in terms of hemodynamic stability of patient requiring General Anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine group | Experimental | Drug: Intravenous morphineHalf of participants will be comprising of morphine group |
| Esmolol group | Experimental | Drug: Intravenous morphineHalf of participants will be comprising of esmolol group |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA 2 patients presenting for elective surgery.
Key exclusion criteria (4 listed)
- Patients having major cardiac disease.
- Metastatic disease.
- Pregnant females.
- Those unwilling to be part of study.
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 |
|---|---|---|
| Intravenous morphineAlso: Intravenous esmololMorphine group(an opioid), participants were given intravenous morphine(an opioid) at induction of General Anaesthesia before laryngoscopy and intubation. The other group,Esmolol group(cardioselective beta blocker), participants were given intravenous esmolol(cardioselective beta blocker) during induction of General Anesthesia before laryngoscopy and intubation. | Drug | Esmolol group, Morphine group |
Primary outcome
Blood pressure
Time frame: 06 months
Change in blood pressure between baseline value and post Intubation value will be measured in millimeter of mercury (mmHg).
Pulse rate
Time frame: 06 months
Change in pulse rate between baseline value and post intubation value will be measured per minute.
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 4 Oct 2023.
- Individual participant dataSharing planned: No
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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 1/2 study testing Intravenous morphine in people with Intubation Complication, run by Pakistan Navy Station Shifa Hospital 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 1 inclusion and 4 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 4 Oct 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Blood pressure (time frame: 06 months). 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 4 Oct 2023.